The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Pain Management Generator-td, Models: Pmg-115-td And Pmg-230-td.
| Device ID | K072478 |
| 510k Number | K072478 |
| Device Name: | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2007-12-19 |
| Summary: | summary |