Marrow Cellution Bone Marrow Aspiration Needle

Instrument, Biopsy

RANFAC CORP

The following data is part of a premarket notification filed by Ranfac Corp with the FDA for Marrow Cellution Bone Marrow Aspiration Needle.

Pre-market Notification Details

Device IDK150563
510k NumberK150563
Device Name:Marrow Cellution Bone Marrow Aspiration Needle
ClassificationInstrument, Biopsy
Applicant RANFAC CORP 30 DOHERTY AVENUE P.O. BOX 635 Avon,  MA  02322
ContactChristopher P. Whelan
CorrespondentChristopher P. Whelan
RANFAC CORP 30 DOHERTY AVENUE P.O. BOX 635 Avon,  MA  02322
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-06
Decision Date2015-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10857878007313 K150563 000
10850023741469 K150563 000
10850023741476 K150563 000
10850023741483 K150563 000
10850023741490 K150563 000
00850023741509 K150563 000
10850023741445 K150563 000
10850023741223 K150563 000
10850023741247 K150563 000
10850023741452 K150563 000
10850023741537 K150563 000
10850023741520 K150563 000
10850023741957 K150563 000
10850023741940 K150563 000
10850023741902 K150563 000
10850023741773 K150563 000
10858690006140 K150563 000
10858690006157 K150563 000
00850023741585 K150563 000
10850023741513 K150563 000
10850023741155 K150563 000
10850023741087 K150563 000
00857878007828 K150563 000
00857878007453 K150563 000
20858690006079 K150563 000
20858690006086 K150563 000
00858690006211 K150563 000
00858690006228 K150563 000
20858690006253 K150563 000
20858690006284 K150563 000
00858690006334 K150563 000
20857878007358 K150563 000
20857878007273 K150563 000
20857878007204 K150563 000
20858690006000 K150563 000
20858690006017 K150563 000
10857878007948 K150563 000
10857878007931 K150563 000
20857878007037 K150563 000
20857878007082 K150563 000
20857878007099 K150563 000
20857878007198 K150563 000
20858690006703 K150563 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.