The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Pain Management Single-use Probe.
| Device ID | K071745 |
| 510k Number | K071745 |
| Device Name: | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-27 |
| Decision Date | 2007-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10680651124828 | K071745 | 000 |
| 10680651125207 | K071745 | 000 |
| 10680651125238 | K071745 | 000 |
| 10680651125245 | K071745 | 000 |
| 10680651125269 | K071745 | 000 |
| 10680651986938 | K071745 | 000 |
| 10193493986931 | K071745 | 000 |
| 10193493124821 | K071745 | 000 |
| 10193493124845 | K071745 | 000 |
| 10680651125191 | K071745 | 000 |
| 10680651125184 | K071745 | 000 |
| 10680651125160 | K071745 | 000 |
| 10680651124842 | K071745 | 000 |
| 10680651124880 | K071745 | 000 |
| 10680651124897 | K071745 | 000 |
| 10680651124934 | K071745 | 000 |
| 10680651124958 | K071745 | 000 |
| 10680651125047 | K071745 | 000 |
| 10680651125139 | K071745 | 000 |
| 10680651125153 | K071745 | 000 |
| 10193493124883 | K071745 | 000 |
| 10193493124890 | K071745 | 000 |
| 10193493124937 | K071745 | 000 |
| 10680651478761 | K071745 | 000 |
| 10680651478778 | K071745 | 000 |
| 10680651111842 | K071745 | 000 |
| 10680651125023 | K071745 | 000 |
| 10680651125061 | K071745 | 000 |
| 10680651125214 | K071745 | 000 |
| 10680651125481 | K071745 | 000 |
| 30680651986789 | K071745 | 000 |
| 10193493125262 | K071745 | 000 |
| 10193493125248 | K071745 | 000 |
| 10193493125231 | K071745 | 000 |
| 10193493124951 | K071745 | 000 |
| 10193493125040 | K071745 | 000 |
| 10193493125132 | K071745 | 000 |
| 10193493125156 | K071745 | 000 |
| 10193493125163 | K071745 | 000 |
| 10193493125187 | K071745 | 000 |
| 10193493125194 | K071745 | 000 |
| 10193493125200 | K071745 | 000 |
| 30680651997082 | K071745 | 000 |