The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Ranfac Bone Marrow Aspiration Needle.
Device ID | K131157 |
510k Number | K131157 |
Device Name: | RANFAC BONE MARROW ASPIRATION NEEDLE |
Classification | Instrument, Biopsy |
Applicant | RANFAC CORP. 30 Doherty Avenue, P.O. Box 635 Avon Industrial Park Avon, MA 02322 |
Contact | Christopher P Whelan |
Correspondent | Christopher P Whelan RANFAC CORP. 30 Doherty Avenue, P.O. Box 635 Avon Industrial Park Avon, MA 02322 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-24 |
Decision Date | 2013-10-22 |
Summary: | summary |