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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 K952334
Device Name DRESSING CHANGE TRAY
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Applicant Contact EILEEN RAMA
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Correspondent Contact EILEEN RAMA
Regulation Number880.5075
Classification Product Code
MCY  
Date Received05/18/1995
Decision Date 07/14/1995
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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