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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K930457
Device Name MEDIMAC BANDAGE
Applicant
ENQUAY PHARMACEUTICAL
2840 N.W. 2ND AVE.
SUITE 213
BOCA RATON,  FL  33431
Applicant Contact BERNARD KOROL
Correspondent
ENQUAY PHARMACEUTICAL
2840 N.W. 2ND AVE.
SUITE 213
BOCA RATON,  FL  33431
Correspondent Contact BERNARD KOROL
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/28/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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