The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Ranfac Cut Biopsy Needle.
| Device ID | K864139 |
| 510k Number | K864139 |
| Device Name: | RANFAC CUT BIOPSY NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Contact | Dennis E Fowler |
| Correspondent | Dennis E Fowler RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-22 |
| Decision Date | 1986-11-05 |