The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Duocool Pain Management Probe, Model Osp-17-180-20.
| Device ID | K101372 |
| 510k Number | K101372 |
| Device Name: | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2010-08-10 |
| Summary: | summary |