The following data is part of a premarket notification filed by New Business Development, Llc with the FDA for Nbd Disposable Rf Cannulae.
| Device ID | K032196 |
| 510k Number | K032196 |
| Device Name: | NBD DISPOSABLE RF CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | NEW BUSINESS DEVELOPMENT, LLC 605 INDUSTRIAL COURT Woodstock, GA 30189 |
| Contact | Timothy B Lusby |
| Correspondent | Timothy B Lusby NEW BUSINESS DEVELOPMENT, LLC 605 INDUSTRIAL COURT Woodstock, GA 30189 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40195327047031 | K032196 | 000 |
| 40195327493203 | K032196 | 000 |
| 40195327493180 | K032196 | 000 |
| 40195327493173 | K032196 | 000 |
| M661SCV201010 | K032196 | 000 |
| M661SCV200510 | K032196 | 000 |
| M661SCV200505 | K032196 | 000 |
| M661SCV181510 | K032196 | 000 |
| M661SCV181010 | K032196 | 000 |