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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 K852120
Device Name FORCEPS, BIOPSY(NON RIGID)
Applicant
SCHOLTEN SURGICAL INSTRUMENTS, INC.
707 WARRINGTON AVE.
REDWOOD CITY,  CA  94063
Applicant Contact JAKE(JACOBUS) SCHOLT
Correspondent
SCHOLTEN SURGICAL INSTRUMENTS, INC.
707 WARRINGTON AVE.
REDWOOD CITY,  CA  94063
Correspondent Contact JAKE(JACOBUS) SCHOLT
Regulation Number878.4800
Classification Product Code
GEN  
Date Received05/15/1985
Decision Date 07/02/1985
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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