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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 K951295
Device Name STERRAD STERILIZATION POUCH
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact PAT AMTOWER
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact PAT AMTOWER
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/22/1995
Decision Date 05/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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