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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Board, Arm (With Cover), Sterile
510(k) Number K882524
Device Name UNIVERSALLY ADJUSTABLE ARMBOARD
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 Number878.3910
Classification Product Code
BTX  
Date Received06/17/1988
Decision Date 07/08/1988
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
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