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510(k) K822240

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. by American Mcgaw — Product Code KFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
July 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device Class
Class II
Regulation Number
890.3500
Review Panel
PM
Submission Type

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