The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Model 504-s External Infusion Pump For Diabetics.
Device ID | K864517 |
510k Number | K864517 |
Device Name: | MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS |
Classification | Pump, Infusion |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | William H Duffell |
Correspondent | William H Duffell MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-17 |
Decision Date | 1986-12-12 |