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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K980673
Device Name SPYROSORB FOAM ISLAND WOUND 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
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/20/1998
Decision Date 05/21/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
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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