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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 K941748
Device Name STERI-VAC GAS STERILIZER MODEL 8XL
Applicant
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Applicant Contact MARVIN L HART
Correspondent
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Correspondent Contact MARVIN L HART
Regulation Number880.6860
Classification Product Code
FLF  
Date Received04/08/1994
Decision Date 12/02/1994
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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