The following data is part of a premarket notification filed by Mist, Inc. with the FDA for Mist Endoscopic Needles.
| Device ID | K951648 |
| 510k Number | K951648 |
| Device Name: | MIST ENDOSCOPIC NEEDLES |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-05-12 |