The following data is part of a premarket notification filed by Mist, Inc. with the FDA for Mist Electrosurgical Probes, Various Styles & Sizes, Surgical Instruments Used During Endoscopic Procedures.
| Device ID | K952290 |
| 510k Number | K952290 |
| Device Name: | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES |
| Classification | Electrode, Electrosurgical |
| Applicant | MIST, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula MIST, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-06-23 |