The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Pain Management Cooled Probe, Model Pmpc-18-150-6.
| Device ID | K053082 |
| 510k Number | K053082 |
| Device Name: | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2005-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193493442010 | K053082 | 000 |
| 10193493442109 | K053082 | 000 |
| 10680651442106 | K053082 | 000 |
| 10680651442090 | K053082 | 000 |
| 10680651442069 | K053082 | 000 |
| 10680651442052 | K053082 | 000 |
| 10680651442038 | K053082 | 000 |
| 10680651442014 | K053082 | 000 |
| 10680651441949 | K053082 | 000 |
| 10680651441932 | K053082 | 000 |
| 10680651440775 | K053082 | 000 |
| 10193493393180 | K053082 | 000 |
| 10193493440754 | K053082 | 000 |
| 00193493441945 | K053082 | 000 |
| 00193493441938 | K053082 | 000 |
| 00193493440771 | K053082 | 000 |
| 00193493406081 | K053082 | 000 |
| 00193493405893 | K053082 | 000 |
| 10193493997159 | K053082 | 000 |
| 10193493997142 | K053082 | 000 |
| 10193493442024 | K053082 | 000 |
| 10193493441959 | K053082 | 000 |
| 10193493441911 | K053082 | 000 |
| 10680651440768 | K053082 | 000 |