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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Elastic
510(k) Number K800197
Device Name ANAGO DISP., ALL PURPOSE PATIENT REST.
Applicant
ANAGO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ANAGO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5075
Classification Product Code
FQM  
Date Received01/30/1980
Decision Date 02/26/1980
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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