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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
510(k) Number K083424
Device Name BUSSE SURGICAL DRAPE
Applicant
Busse Hosipital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hosipital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/19/2008
Decision Date 02/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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