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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Cine Film
510(k) Number K861928
Device Name STERILE O. R. TOWEL
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact KATHY RUSSELL
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact KATHY RUSSELL
Regulation Number892.1900
Classification Product Code
IXX  
Date Received05/20/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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