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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K902297
Device Name BUSSE BAC/SHIELD
Applicant
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Applicant Contact PARTHA BASUMALLIK
Correspondent
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Correspondent Contact PARTHA BASUMALLIK
Regulation Number868.6810
Classification Product Code
BSY  
Date Received05/23/1990
Decision Date 08/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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