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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mattress, flotation therapy, non-powered
510(k) Number K760963
Device Name DECUBITUS MATTRESS
Applicant
ARCO MEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ARCO MEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5150
Classification Product Code
IKY  
Date Received11/04/1976
Decision Date 11/18/1976
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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