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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 K920554
Device Name KOLD WRAP STERILE BURN DRESSING
Applicant
Kold Products
2026 Sterling Ave.
Elkhart,  IN  46516
Applicant Contact JOHN LEVY
Correspondent
Kold Products
2026 Sterling Ave.
Elkhart,  IN  46516
Correspondent Contact JOHN LEVY
Classification Product Code
MGQ  
Date Received02/06/1992
Decision Date 02/19/1993
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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