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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Formalin Ammonium Bromide
510(k) Number K950560
Device Name SALINE SOLUTINE, STERILE
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 Number864.4010
Classification Product Code
IGE  
Date Received02/08/1995
Decision Date 05/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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