The following data is part of a premarket notification filed by Cp Medical with the FDA for Pre-waxed Needles With Gold Fiduciary Markers.
| Device ID | K071550 |
| 510k Number | K071550 |
| Device Name: | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-06 |
| Decision Date | 2007-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021102 | K071550 | 000 |
| 00813787021850 | K071550 | 000 |
| 00813787021843 | K071550 | 000 |
| 00813787021829 | K071550 | 000 |
| 00813787021812 | K071550 | 000 |
| 00813787021805 | K071550 | 000 |
| 00813787021799 | K071550 | 000 |
| 20790986006342 | K071550 | 000 |
| 20790986006335 | K071550 | 000 |
| 20790986006328 | K071550 | 000 |
| 20790986006311 | K071550 | 000 |
| 20790986006304 | K071550 | 000 |
| 00813787021867 | K071550 | 000 |
| 00813787021836 | K071550 | 000 |
| 00813787020983 | K071550 | 000 |
| 00813787021096 | K071550 | 000 |
| 00813787021089 | K071550 | 000 |
| 00813787021072 | K071550 | 000 |
| 00813787021065 | K071550 | 000 |
| 00813787021058 | K071550 | 000 |
| 00813787021041 | K071550 | 000 |
| 00813787021034 | K071550 | 000 |
| 00813787021027 | K071550 | 000 |
| 00813787021010 | K071550 | 000 |
| 00813787021003 | K071550 | 000 |
| 00813787020990 | K071550 | 000 |
| 20790986006298 | K071550 | 000 |