The following data is part of a premarket notification filed by Walsh Medical Devices, Inc. with the FDA for Unit, Cautery, Tehrmal,battery-powered.
| Device ID | K030158 |
| 510k Number | K030158 |
| Device Name: | UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WALSH MEDICAL DEVICES, INC. 1200 SOUTH SERVICE RD. WEST UNIT 3 Oakville, Ontario, CA L6l 5t7 |
| Contact | David Stiles |
| Correspondent | David Stiles WALSH MEDICAL DEVICES, INC. 1200 SOUTH SERVICE RD. WEST UNIT 3 Oakville, Ontario, CA L6l 5t7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-16 |
| Decision Date | 2003-07-17 |
| Summary: | summary |