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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K874186
Device Name BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE
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
Classification Product Code
LDQ
Date Received10/14/1987
Decision Date 12/29/1987
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
Predetermined Change
Control Plan Authorized		 No
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