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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K830281
Device Name SKIN SCRUB PREP. TRAY
Applicant
ZOA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ZOA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/26/1983
Decision Date 03/11/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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