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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K934105
Device Name DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES
Applicant
Surgical Innovations Corp.
6 Pheasant Ln.
Claremont,  NH  03743
Applicant Contact JACK YAZINSKI
Correspondent
Surgical Innovations Corp.
6 Pheasant Ln.
Claremont,  NH  03743
Correspondent Contact JACK YAZINSKI
Regulation Number878.4740
Classification Product Code
GAG  
Date Received08/23/1993
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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