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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K960456
Device Name DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
Applicant
Denver Biomaterials, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Applicant Contact LYNNE LEONARD
Correspondent
Denver Biomaterials, Inc.
6851 Hwy. 73
Evergreen,  CO  80439
Correspondent Contact LYNNE LEONARD
Regulation Number878.4800
Classification Product Code
KDD  
Date Received01/30/1996
Decision Date 04/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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