N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE

Biopsy Needle

AVID N.I.T., INC.

The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for N,i.t., Inc. Automatic Cutting Biopsy Needle.

Pre-market Notification Details

Device IDK983218
510k NumberK983218
Device Name:N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
ClassificationBiopsy Needle
Applicant AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar,  FL  34677
ContactJoseph E Harms
CorrespondentJoseph E Harms
AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar,  FL  34677
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-14
Decision Date1998-11-06

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