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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheet, Burn
510(k) Number K841898
Device Name FIRST RESPONSE EMERG. MEDICSL - BURNS
Applicant
REED PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
REED PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5180
Classification Product Code
FPY  
Date Received05/07/1984
Decision Date 08/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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