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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 K013715
Device Name RE-USABLE STERILIZATION POUCH / BAG
Applicant
Quality Products of Montana
100 N. Johnson #7
Missoula,  MT  59801
Applicant Contact LARRY LARSON
Correspondent
Quality Products of Montana
100 N. Johnson #7
Missoula,  MT  59801
Correspondent Contact LARRY LARSON
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
KCT  
Date Received11/08/2001
Decision Date 04/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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