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510(k) K941748

STERI-VAC GAS STERILIZER MODEL 8XL by 3M Health Care, Ltd. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1994
Date Received
April 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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