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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 K982804
Device Name SPYROGEL HYDROGEL WOUND AND BURN DRESSING
Applicant
Innovative Technologies (Us), Inc.
581 Conference Place
Golden,,  CO  80401
Applicant Contact JULIE CHAFFEE
Correspondent
Innovative Technologies (Us), Inc.
581 Conference Place
Golden,,  CO  80401
Correspondent Contact JULIE CHAFFEE
Classification Product Code
MGQ  
Date Received08/10/1998
Decision Date 12/16/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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