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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K852332
Device Name TABLE ACCESSORIES, OPERATING ROOM
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 Number878.4950
Classification Product Code
BWN  
Date Received05/31/1985
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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