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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K070432
Device Name GENERAL SURGERY DRAPES
Applicant
WELMED INC.
1340 WEST PENNSYLVANIA AVENUE
SAN DIEGO,  CA  92103
Applicant Contact Glen Feye
Correspondent
WELMED INC.
1340 WEST PENNSYLVANIA AVENUE
SAN DIEGO,  CA  92103
Correspondent Contact Glen Feye
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/13/2007
Decision Date 09/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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