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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K963260
Device Name DRESSING CHANGE TRAYS
Applicant
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Applicant Contact EILEEN RAMA
Correspondent
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Correspondent Contact EILEEN RAMA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/20/1996
Decision Date 11/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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