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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 K851258
Device Name WECK LX TM SKIN STAPLER
Applicant
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Applicant Contact RUSSELL W BOONE
Correspondent
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Correspondent Contact RUSSELL W BOONE
Regulation Number878.4740
Classification Product Code
GAG  
Date Received03/28/1985
Decision Date 06/07/1985
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
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