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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K854146
Device Name SURGICAL & DENTAL INSTRUMENT
Applicant
BAORT, INC.
P.O. BOX 682
SOUTH ORANGE,  NJ  07079
Applicant Contact BAYO OSHINNAIYE
Correspondent
BAORT, INC.
P.O. BOX 682
SOUTH ORANGE,  NJ  07079
Correspondent Contact BAYO OSHINNAIYE
Regulation Number878.4800
Classification Product Code
GEN  
Date Received10/11/1985
Decision Date 11/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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