RANFAC CUT BIOPSY NEEDLE

Needle, Aspiration And Injection, Disposable

RANFAC CORP.

The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Ranfac Cut Biopsy Needle.

Pre-market Notification Details

Device IDK864139
510k NumberK864139
Device Name:RANFAC CUT BIOPSY NEEDLE
ClassificationNeedle, Aspiration And Injection, Disposable
Applicant RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon,  MA  02322
ContactDennis E Fowler
CorrespondentDennis E Fowler
RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon,  MA  02322
Product CodeGAA  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-22
Decision Date1986-11-05

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