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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K902036
Device Name STERI-VAC GAS STERILIZER MODEL 5XL
Applicant
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Applicant Contact MARVIN L HART
Correspondent
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Correspondent Contact MARVIN L HART
Regulation Number880.6860
Classification Product Code
FLF  
Date Received05/03/1990
Decision Date 07/19/1990
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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