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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 K770391
Device Name COVER, ARMBOARD, DISPOSABLE
Applicant
PRECEPT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PRECEPT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.3910
Classification Product Code
BTX  
Date Received02/28/1977
Decision Date 03/07/1977
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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