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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K962605
Device Name PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
Applicant
Surgicot, Inc.
4018 Patriot Dr.,
P.O. Box 13956
Research Triangle Park,  NC  27709
Applicant Contact BEN B BROCK
Correspondent
Surgicot, Inc.
4018 Patriot Dr.,
P.O. Box 13956
Research Triangle Park,  NC  27709
Correspondent Contact BEN B BROCK
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/02/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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