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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, Ethylene-Oxide Gas Aerator
510(k) Number K904921
Device Name STERI-VAC(TM) AERATOR MODEL XL
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 Number880.6100
Classification Product Code
FLI  
Date Received10/31/1990
Decision Date 12/05/1990
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
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