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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 K912160
Device Name BUTTERFLY DRESSING
Applicant
DURDEN ENTERPRISES, INC.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Applicant Contact KOTULA COOK
Correspondent
DURDEN ENTERPRISES, INC.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact KOTULA COOK
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/16/1991
Decision Date 10/09/1991
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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