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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 K082297
Device Name BUSSE SURGICAL DRAPE
Applicant
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/12/2008
Decision Date 12/09/2008
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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