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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor
510(k) Number K852330
Device Name RETRACTOR, SURGICAL
Applicant
SCHOLTEN SURGICAL INSTRUMENTS, INC.
707 WARRINGTON AVE.
REDWOOD CITY,  CA  94063
Applicant Contact JACOBUS SCHOLTEN
Correspondent
SCHOLTEN SURGICAL INSTRUMENTS, INC.
707 WARRINGTON AVE.
REDWOOD CITY,  CA  94063
Correspondent Contact JACOBUS SCHOLTEN
Regulation Number878.4800
Classification Product Code
GAD  
Date Received05/31/1985
Decision Date 06/27/1985
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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