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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 K973638
Device Name N.I.T., INC. NEEDLE GUIDING TEMPLATE
Applicant
Avid N.I.T., Inc.
390 Scarlet Blvd.
Oldsmar,  FL  34677
Applicant Contact JOSEPH E HARMS
Correspondent
Avid N.I.T., Inc.
390 Scarlet Blvd.
Oldsmar,  FL  34677
Correspondent Contact JOSEPH E HARMS
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received09/24/1997
Decision Date 12/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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