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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing kit
510(k) Number K912116
Device Name PRESSURE SORE MANAGEMENT KIT
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.5075
Classification Product Code
MCY  
Date Received05/14/1991
Decision Date 10/18/1991
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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