The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed 508 Insulin Pump.
Device ID | K990801 |
510k Number | K990801 |
Device Name: | MINIMED 508 INSULIN PUMP |
Classification | Pump, Infusion, Insulin |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Don Selvey |
Correspondent | Don Selvey MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-10 |
Decision Date | 1999-06-08 |
Summary: | summary |