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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
Contact muhamad ansari
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/19/2008
Decision Date 02/26/2009
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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