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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 K052395
Device Name STERILE EQUIPMENT COVERS
Applicant
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Applicant Contact Michelle J Badal
Correspondent
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Correspondent Contact Michelle J Badal
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/31/2005
Decision Date 12/01/2005
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
Recalls CDRH Recalls
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