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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861453
Device Name STAGNONE SWIVEL-JOINT NEEDLE
Applicant
Radtech, Inc.
2610 San Mateo, NE Suite D
Albuquerque,  NM  87110
Applicant Contact JOHN SOMERS
Correspondent
Radtech, Inc.
2610 San Mateo, NE Suite D
Albuquerque,  NM  87110
Correspondent Contact JOHN SOMERS
Date Received04/18/1986
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
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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