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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 K853312
Device Name ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
Applicant
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact RUSSELL JONES
Correspondent
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact RUSSELL JONES
Regulation Number878.4800
Classification Product Code
DWO  
Date Received08/07/1985
Decision Date 09/12/1985
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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