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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 K926127
Device Name SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM
Applicant
Life Medical Sciences, Inc.
1300 N. 17th St.
Suite 300
Arlington,  VA  22209
Applicant Contact GLENN A RAHMOELLER
Correspondent
Life Medical Sciences, Inc.
1300 N. 17th St.
Suite 300
Arlington,  VA  22209
Correspondent Contact GLENN A RAHMOELLER
Regulation Number878.4740
Classification Product Code
GAG  
Date Received12/04/1992
Decision Date 06/24/1993
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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