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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Removable (Skin)
510(k) Number K963234
Device Name STAPLE REMOVAL KIT
Applicant
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number878.4760
Classification Product Code
GDT  
Subsequent Product Code
MCZ  
Date Received08/19/1996
Decision Date 10/21/1996
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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