The following data is part of a premarket notification filed by Mist, Inc. with the FDA for Mist Micro Interchangeable Scope System (tm).
| Device ID | K970937 |
| 510k Number | K970937 |
| Device Name: | MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-13 |
| Decision Date | 1997-09-26 |
| Summary: | summary |