The following data is part of a premarket notification filed by Minimally Invasive Surgical Technologies, Inc. with the FDA for Mist Microsurgical Monopolar Forceps.
| Device ID | K931275 |
| 510k Number | K931275 |
| Device Name: | MIST MICROSURGICAL MONOPOLAR FORCEPS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. CAROLANN KATULA-COOK 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | C/o M.d.i. |
| Correspondent | C/o M.d.i. MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. CAROLANN KATULA-COOK 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-08-05 |