The following data is part of a premarket notification filed by Minimally Invasive Surgical Technologies, Inc. with the FDA for Mist Reducer Sleeves.
| Device ID | K951398 |
| 510k Number | K951398 |
| Device Name: | MIST REDUCER SLEEVES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. 55 NORTHERN BLVD. SUITE 410 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 | 1995-03-28 |
| Decision Date | 1995-05-03 |