The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Baylis Medical Rf Perforation Probe V2.0.
| Device ID | K132374 |
| 510k Number | K132374 |
| Device Name: | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario, CA L4w 5s4 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447002161 | K132374 | 000 |
| 00685447002154 | K132374 | 000 |
| 00685447002147 | K132374 | 000 |