The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Single Action Biopsy Needle, Model Rcbs: Xx Gauge, Xx Length, Xx Throw.
| Device ID | K012224 |
| 510k Number | K012224 |
| Device Name: | SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW |
| Classification | Instrument, Biopsy |
| Applicant | RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Contact | George J Hattub |
| Correspondent | George J Hattub RANFAC CORP. 30 DOHERTY AVE., 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 | 2001-06-16 |
| Decision Date | 2001-08-22 |