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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 K812867
Device Name STERI-VAC #400C GAS STERILIZER
Applicant
3M COMPANY
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Correspondent
3M COMPANY
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Regulation Number880.6860
Classification Product Code
FLF  
Date Received10/13/1981
Decision Date 11/02/1981
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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