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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Thigh/Knee/Shank/Ankle/Foot, External
510(k) Number K822240
Device Name ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
Applicant
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Applicant Contact FLOYD BENJAMIN
Correspondent
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Correspondent Contact FLOYD BENJAMIN
Regulation Number890.3500
Classification Product Code
KFX  
Date Received07/27/1982
Decision Date 12/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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