The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Weck Electrosurgical Generator #174200.
| Device ID | K902232 |
| 510k Number | K902232 |
| Device Name: | WECK ELECTROSURGICAL GENERATOR #174200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Mattei, Jd |
| Correspondent | Mattei, Jd EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-17 |
| Decision Date | 1990-08-02 |