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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, Occlusive
510(k) Number K974520
Device Name SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
Applicant
Innovative Technologies (Us), Inc.
581 Conference Pl.
Golden,,  CO  80401
Applicant Contact JULIE CHAFFEE
Correspondent
Innovative Technologies (Us), Inc.
581 Conference Pl.
Golden,,  CO  80401
Correspondent Contact JULIE CHAFFEE
Classification Product Code
MGP  
Date Received12/02/1997
Decision Date 02/06/1998
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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