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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K882078
Device Name SPINAL SURGERY FRAME
Applicant
Karlin Technology, Inc.
330 Washington St.
Suite 314
Marina Del Rey,  CA  90292
Applicant Contact MARK WEIDHAAS
Correspondent
Karlin Technology, Inc.
330 Washington St.
Suite 314
Marina Del Rey,  CA  90292
Correspondent Contact MARK WEIDHAAS
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received05/17/1988
Decision Date 06/16/1988
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
Predetermined Change
Control Plan Authorized		 No
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