The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Ranfac Aspiration Needle With Adjustable Guide.
| Device ID | K140991 |
| 510k Number | K140991 |
| Device Name: | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE |
| 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 | 2014-04-17 |
| Decision Date | 2014-09-11 |
| Summary: | summary |