The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Model 304-s External Micro-volume Infusion Pump.
| Device ID | K864327 |
| 510k Number | K864327 |
| Device Name: | MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP |
| Classification | Scale, Patient |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | William Duffell |
| Correspondent | William Duffell MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1987-02-06 |