The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (gss) Needle.
| Device ID | K031344 |
| 510k Number | K031344 |
| Device Name: | RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | RANFAC CORP. 53 KENNEDY RD. Foster, RI 02825 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant RANFAC CORP. 53 KENNEDY RD. Foster, RI 02825 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-29 |
| Decision Date | 2003-05-23 |
| Summary: | summary |