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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K874585
Device Name ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
Applicant
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Applicant Contact MICHAEL MCCALLUM
Correspondent
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Correspondent Contact MICHAEL MCCALLUM
Regulation Number878.4800
Classification Product Code
DWO  
Date Received11/09/1987
Decision Date 12/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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