The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Baylis Medical Company Radiofrequency Perforation Generator.
| Device ID | K122278 |
| 510k Number | K122278 |
| Device Name: | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, CA L4w 5s4 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447000969 | K122278 | 000 |
| 00685447000594 | K122278 | 000 |