The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Mps Myocardial Protection System - Mps 2 Console, Model 5201260.
Device ID | K041979 |
510k Number | K041979 |
Device Name: | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
Contact | Jane Ann Martin |
Correspondent | Jane Ann Martin QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-23 |
Decision Date | 2004-09-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20634624524501 | K041979 | 000 |
20634624522262 | K041979 | 000 |
20634624521265 | K041979 | 000 |
20634624510320 | K041979 | 000 |
20634624514045 | K041979 | 000 |
20634624512317 | K041979 | 000 |
20634624511617 | K041979 | 000 |
20634624511600 | K041979 | 000 |
20634624510290 | K041979 | 000 |