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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 K955476
Device Name DUKAL TRANSPARENT WOUND DRESSING
Applicant
Dukal Corp.
1247 Florida Ave.
Palm Harobor,  FL  34683
Applicant Contact PAT LAMB
Correspondent
Dukal Corp.
1247 Florida Ave.
Palm Harobor,  FL  34683
Correspondent Contact PAT LAMB
Classification Product Code
MGP  
Date Received11/30/1995
Decision Date 01/18/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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