The following data is part of a premarket notification filed by Refractec, Inc. with the FDA for Refractec Mcs-100.
| Device ID | K980522 |
| 510k Number | K980522 |
| Device Name: | REFRACTEC MCS-100 |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | REFRACTEC, INC. 27075 CABOT RD., #115 Laguna Hills, CA 92653 |
| Contact | Mitch Campbell |
| Correspondent | Mitch Campbell REFRACTEC, INC. 27075 CABOT RD., #115 Laguna Hills, CA 92653 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-10 |
| Decision Date | 1998-07-22 |