The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Mps Gravity Flow Control Set.
| Device ID | K983926 |
| 510k Number | K983926 |
| Device Name: | MPS GRAVITY FLOW CONTROL SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CRITICAL DEVICE CORP. 499 NIBUS ST. Brea, CA 92621 |
| Contact | Dan Hyun |
| Correspondent | Dan Hyun CRITICAL DEVICE CORP. 499 NIBUS ST. Brea, CA 92621 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513023531 | K983926 | 000 |