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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K940692
Device Name PLAIN GAUZE DRESSING
Applicant
Medtrax Industries, Inc.
1372 Bennett Dr.
Suite 156
Longwood,  FL  32750
Applicant Contact JUAN ALANA
Correspondent
Medtrax Industries, Inc.
1372 Bennett Dr.
Suite 156
Longwood,  FL  32750
Correspondent Contact JUAN ALANA
Classification Product Code
EFQ  
Date Received02/16/1994
Decision Date 04/14/1994
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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