The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Bmc Rf Cannula.
| Device ID | K972846 |
| 510k Number | K972846 |
| Device Name: | BMC RF CANNULA |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga, CA L4w-4t7 |
| Contact | Kris Shah |
| Correspondent | Kris Shah BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga, CA L4w-4t7 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-01 |
| Decision Date | 1998-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193493986450 | K972846 | 000 |
| 20193493986242 | K972846 | 000 |
| 20193493986228 | K972846 | 000 |
| 10193493385505 | K972846 | 000 |
| 10193493385499 | K972846 | 000 |
| 10193493128669 | K972846 | 000 |
| 10193493125491 | K972846 | 000 |
| 10193493124876 | K972846 | 000 |
| 10193493124852 | K972846 | 000 |
| 10193493124838 | K972846 | 000 |
| 10193493124814 | K972846 | 000 |
| 20193493124804 | K972846 | 000 |
| 10193493124777 | K972846 | 000 |
| 20193493124743 | K972846 | 000 |
| 20193493111835 | K972846 | 000 |
| 10193493986252 | K972846 | 000 |
| 20193493986266 | K972846 | 000 |
| 20193493986273 | K972846 | 000 |
| 10193493986443 | K972846 | 000 |
| 10193493986436 | K972846 | 000 |
| 10193493986429 | K972846 | 000 |
| 20193493986402 | K972846 | 000 |
| 10193493986382 | K972846 | 000 |
| 10193493986375 | K972846 | 000 |
| 10193493986368 | K972846 | 000 |
| 20193493986358 | K972846 | 000 |
| 10193493986344 | K972846 | 000 |
| 10193493986337 | K972846 | 000 |
| 10193493986313 | K972846 | 000 |
| 10193493986306 | K972846 | 000 |
| 10193493986290 | K972846 | 000 |
| 10193493986283 | K972846 | 000 |
| 10193493111821 | K972846 | 000 |