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FDA Product Code

FDA Product Code FXX — Clearance Directory

Device Class
Class II
21 CFR Citation
878.4040

510(k) Clearances — 607 records · page 7 of 7

K-Number Device Name Applicant Decision Date Clearance Type Summary
K780607 MASK, SURGEONS Abco Dealers, Inc. 1978-06-22 Traditional PDF ↗
K780609 MASK, ISOLATION Abco Dealers, Inc. 1978-05-26 Traditional PDF ↗
K780169 MASK, SURGICAL Convertors 1978-02-13 Traditional PDF ↗
K771409 DISP. SURGICAL FACE MASK Precept, Inc. 1977-10-27 Traditional PDF ↗
K770513 MASK, SURGICAL, DISP Acme Automatic Disposable 1977-04-29 Traditional PDF ↗
K770463 MASK, SURGICAL, FACE, DISPOSABLE Precept, Inc. 1977-03-23 Traditional PDF ↗
K760991 SURGINE FACE MASK Surgikos, Inc. 1976-11-16 Traditional PDF ↗

Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.