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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Table Cushion
510(k) Number K874494
Device Name KAMBIN LAMINECTOMY FRAME
Applicant
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Applicant Contact AARON HEINTZ
Correspondent
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Correspondent Contact AARON HEINTZ
Regulation Number878.4950
Classification Product Code
LWG  
Date Received11/02/1987
Decision Date 11/23/1987
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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