The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Bmc Radio Frequency Perforation Generator, Models Rfp-100-115 And Rfp-100-230.
| Device ID | K013904 |
| 510k Number | K013904 |
| Device Name: | BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 |
| 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 | 2001-11-26 |
| Decision Date | 2002-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447001430 | K013904 | 000 |
| 00685447001423 | K013904 | 000 |