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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K843496
Device Name DRAPE SURGICAL UTILITY DRAPE STERILE
Applicant
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact PARTHA BASUMALLIK
Correspondent
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact PARTHA BASUMALLIK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/06/1984
Decision Date 10/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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