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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K833120
Device Name ONE TIME COMPOUND BENZOIN TINCTURE-
Applicant
ACME UNITED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ACME UNITED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/13/1983
Decision Date 12/29/1983
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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