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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 K844417
Device Name APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
Applicant
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Applicant Contact PELLETIER
Correspondent
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Correspondent Contact PELLETIER
Regulation Number878.4740
Classification Product Code
GAG  
Date Received11/15/1984
Decision Date 12/17/1984
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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