The following data is part of a premarket notification filed by Medical Product Specialists with the FDA for Mps Huber Needle Extension Set.
| Device ID | K982047 |
| 510k Number | K982047 |
| Device Name: | MPS HUBER NEEDLE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea, CA 92821 |
| Contact | Dan Hyun |
| Correspondent | Dan Hyun MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea, CA 92821 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-10 |
| Decision Date | 1998-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513023517 | K982047 | 000 |