PRO-B BIOPSY NEEDLE

Biopsy Needle

PROMEDICAL LTD.

The following data is part of a premarket notification filed by Promedical Ltd. with the FDA for Pro-b Biopsy Needle.

Pre-market Notification Details

Device IDK951598
510k NumberK951598
Device Name:PRO-B BIOPSY NEEDLE
ClassificationBiopsy Needle
Applicant PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff,  NJ  07481
ContactHenry V Sierakowski
CorrespondentHenry V Sierakowski
PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff,  NJ  07481
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-07
Decision Date1995-04-21

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