The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Paradigm Sof-set Micro Qr, Models 324 And 325.
Device ID | K001827 |
510k Number | K001827 |
Device Name: | PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 |
Classification | Set, Administration, Intravascular |
Applicant | MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Jennifer Lyons |
Correspondent | Jennifer Lyons MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-16 |
Decision Date | 2000-08-18 |