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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Ice
510(k) Number K833872
Device Name SAV-A-LIMB
Applicant
SIL-MED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SIL-MED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6050
Classification Product Code
KYR  
Date Received11/08/1983
Decision Date 02/04/1984
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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