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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K954185
Device Name RE-BAG MULTI-USE POUCH, LARGE & SMALL
Applicant
Miltex, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Miltex, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/06/1995
Decision Date 12/04/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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