The following data is part of a premarket notification filed by Mist, Inc. with the FDA for Mist Electrosurgical Probes, Various Styles & Sizes.
Device ID | K952323 |
510k Number | K952323 |
Device Name: | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES |
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 | 1995-05-18 |
Decision Date | 1995-06-23 |