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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 K123678
Device Name HYALMIX CREAM
Applicant
Igi Laboratories, Inc.
105 Lincoln Ave.
Buena,  NJ  08310
Applicant Contact FREDERICK WEISS
Correspondent
Beach Products, Inc.
310 W. Deleon St.
Tampa,  FL  33609
Correspondent Contact Marc D. Wita
Classification Product Code
FRO  
Date Received11/30/2012
Decision Date 12/16/2013
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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