The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Wells Johnson Weco Monopolar/frazier Suction Probe.
| Device ID | K945805 |
| 510k Number | K945805 |
| Device Name: | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
| Contact | Brenda Hunt |
| Correspondent | Brenda Hunt WELLS JOHNSON CO. 8075 E RESEARCH CT., STE. 101 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1994-12-13 |