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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K862805
Device Name ANGIOMED VAC-U-CUT BIOPSY NEEDLE
Applicant
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number878.4800
Classification Product Code
GDM  
Date Received07/22/1986
Decision Date 09/29/1986
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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