The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Mti 1 Ml Syringe.
| Device ID | K991225 |
| 510k Number | K991225 |
| Device Name: | MTI 1 ML SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Maria D Ochoa |
| Correspondent | Maria D Ochoa MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462006034 | K991225 | 000 |