The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Millipore Dual Rate Intravenous Cassette.
Device ID | K811432 |
510k Number | K811432 |
Device Name: | MILLIPORE DUAL RATE INTRAVENOUS CASSETTE |
Classification | Controller, Infusion, Intravascular, Electronic |
Applicant | MILLIPORE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LDR |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-22 |
Decision Date | 1981-07-13 |