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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple Removal Kit
510(k) Number K844110
Device Name XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001
Applicant
Pelco, Inc.
1040 Harbor Dr.
Annapolis,  MD  21403
Applicant Contact WALLACE J ROGOZINSK
Correspondent
Pelco, Inc.
1040 Harbor Dr.
Annapolis,  MD  21403
Correspondent Contact WALLACE J ROGOZINSK
Regulation Number878.4760
Classification Product Code
PYE  
Date Received10/23/1984
Decision Date 11/19/1984
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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