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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K945835
Device Name ARGIDENE(TM) GEL
Applicant
Telios Pharmaceuticals, Inc.
4757 Nexus Centre Dr.
San Diego,  CA  92121
Applicant Contact JOYCE WILLIAMS
Correspondent
Telios Pharmaceuticals, Inc.
4757 Nexus Centre Dr.
San Diego,  CA  92121
Correspondent Contact JOYCE WILLIAMS
Classification Product Code
MGQ  
Date Received11/29/1994
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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