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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K921886
Device Name NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
Applicant
Needle Technologies, Inc.
P.O. Box 1543
Palm Harbor,  FL  34682
Applicant Contact DON RYAN
Correspondent
Needle Technologies, Inc.
P.O. Box 1543
Palm Harbor,  FL  34682
Correspondent Contact DON RYAN
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received04/21/1992
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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