The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Medical Rf Perforation Probe, Model Rfp-265.
| Device ID | K010265 |
| 510k Number | K010265 |
| Device Name: | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7 |
| Contact | Kris Shah |
| Correspondent | Kris Shah BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-26 |
| Decision Date | 2001-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447000976 | K010265 | 000 |
| 00685447000600 | K010265 | 000 |
| 07540299000174 | K010265 | 000 |