The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Breast & Foreign Body Localization Instrument.
| Device ID | K845038 |
| 510k Number | K845038 |
| Device Name: | BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT |
| Classification | Guide, Needle, Surgical |
| Applicant | RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Contact | Michael P Cody |
| Correspondent | Michael P Cody RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858690006659 | K845038 | 000 |
| M9796000402M9 | K845038 | 000 |
| M9796000403M9 | K845038 | 000 |
| 20858690006598 | K845038 | 000 |
| 20858690006604 | K845038 | 000 |
| 20858690006611 | K845038 | 000 |
| 20858690006628 | K845038 | 000 |
| 20858690006635 | K845038 | 000 |
| 20858690006642 | K845038 | 000 |
| M9796000401M9 | K845038 | 000 |