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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, Drug
510(k) Number K933966
Device Name SURE-ADAPT NON-ADHERING DRESSING
Applicant
Medtrax Industries, Inc.
1372 Bennett Dr.
Suite 156
Longwood,  FL  32750
Applicant Contact JUAN E ALANA
Correspondent
Medtrax Industries, Inc.
1372 Bennett Dr.
Suite 156
Longwood,  FL  32750
Correspondent Contact JUAN E ALANA
Classification Product Code
FRO  
Date Received08/16/1993
Decision Date 10/28/1993
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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