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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K012816
Device Name DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
Applicant
Dynarex Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Applicant Contact JOHN GAGLIARDI
Correspondent
Dynarex Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Correspondent Contact JOHN GAGLIARDI
Classification Product Code
FRO  
Date Received08/22/2001
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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