The following data is part of a premarket notification filed by Intelligent Medicine, Inc. with the FDA for Intelliject Medication Syringe.
| Device ID | K861208 |
| 510k Number | K861208 |
| Device Name: | INTELLIJECT MEDICATION SYRINGE |
| Classification | Pump, Infusion |
| Applicant | INTELLIGENT MEDICINE, INC. 253 ADAMS ST. Denver, CO 80206 |
| Contact | David C Howson |
| Correspondent | David C Howson INTELLIGENT MEDICINE, INC. 253 ADAMS ST. Denver, CO 80206 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-06-30 |