The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Pain Management Probe/pmp-20-145 And Baylis Pain Management Connector Cable/pmx-bay-bay.
Device ID | K002389 |
510k Number | K002389 |
Device Name: | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY |
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 | 2000-08-04 |
Decision Date | 2000-10-23 |