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 |
|---|---|---|
| M661SCV181505 | K032196 | 000 |
| M661SST201510 | K032196 | 000 |
| M661SST201515 | K032196 | 000 |
| M661SST201520 | K032196 | 000 |
| M661SST210504 | K032196 | 000 |
| M661SST210505 | K032196 | 000 |
| M661SST211010 | K032196 | 000 |
| M661SST220504 | K032196 | 000 |
| M661SST220510 | K032196 | 000 |
| M661SST221005 | K032196 | 000 |
| M661SST221010 | K032196 | 000 |
| M661S181505CVSQ1 | K032196 | 000 |
| M661SST201010 | K032196 | 000 |
| M661SST181510 | K032196 | 000 |
| M661SCV201005 | K032196 | 000 |
| M661SCV201505 | K032196 | 000 |
| M661SCV201510 | K032196 | 000 |
| M661SCV201515 | K032196 | 000 |
| M661SCV220505 | K032196 | 000 |
| M661SCV220510 | K032196 | 000 |
| M661SCV221005 | K032196 | 000 |
| M661SCV221010 | K032196 | 000 |
| M661SST181005 | K032196 | 000 |
| M661SST181010 | K032196 | 000 |
| M661SST181505 | K032196 | 000 |
| M661S181505STSQ1 | K032196 | 000 |
| M661S181510CVSQ1 | K032196 | 000 |
| M661SST201005 | K032196 | 000 |
| M661SST201505 | K032196 | 000 |
| M661SST211005 | K032196 | 000 |
| M661SCV181010 | K032196 | 000 |
| M661SCV181510 | K032196 | 000 |
| M661SCV200505 | K032196 | 000 |
| M661SCV200510 | K032196 | 000 |
| M661SCV201010 | K032196 | 000 |
| 40195327493173 | K032196 | 000 |
| 40195327493180 | K032196 | 000 |
| 40195327493203 | K032196 | 000 |
| M661SCV181005 | K032196 | 000 |
| M661SCV161510 | K032196 | 000 |
| M661S181510STSQ1 | K032196 | 000 |
| M661S201010CVSQ1 | K032196 | 000 |
| M661S201010STSQ1 | K032196 | 000 |
| M661S201505CVSQ1 | K032196 | 000 |
| M661S201505STSQ1 | K032196 | 000 |
| M661S201510CVSQ1 | K032196 | 000 |
| M661S201510STSQ1 | K032196 | 000 |
| M661S221010CVSQ1 | K032196 | 000 |
| M661S221505STSQ1 | K032196 | 000 |
| M661SBC201010 | K032196 | 000 |
| M661SCV161010 | K032196 | 000 |
| 40195327047031 | K032196 | 000 |