510(k) Premarket Notification - Accessdata.

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510(k) Premarket Notification

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A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

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510K Number

Type Traditional Special Abbreviated

Product Code

Center

Biologics Evaluation and Research Devices and Radiological Health

Combination Products

Applicant Name

Cleared/Approved In Vitro Products

Device Name

Redacted FOIA 510(k)

Panel

Anesthesiology General Hospital Ear Nose & Throat General & Plastic Surgery Immunology Ophthalmic Radiology Cardiovascular Gastroenterology/Urology Microbiology Orthopedic Clinical Chemistry Neurology Pathology Toxicology Dental Hematology Obstetrics/Gynecology Physical Medicine Molecular Genetics

Third Party Reviewed

Decision

SE - POSTMARKET SURVEILLANCE REQUIRED (SESP) SE - WITH LIMITATIONS (SESU) SE SUBJECT TO TRACKING REG (ST) SE SUBJECT TO TRAKING & PMS (PT) SUBST EQUIV (SESE) SUBST EQUIV - KIT (SESK) SUBST EQUIV - KIT WITH DRUGS (SEKD) SUBST EQUIV - MARKET AFTER INSPECTION (SI) SUBST EQUIV - WITH DRUG (SESD) SUBST EQUIV FOR SOME INDICATIONS (SN)

Decision Date

Clinical Trials

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Decision Date (descending) Decision Date (ascending) Device Name (A-Z) Device Name (Z-A) Applicant Name (A-Z) Applicant Name (Z-A) 510(k) Number (descending) 510(k) Number (ascending)

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