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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
Recalls CDRH Recalls
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