The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Cdc Vial And Bag Access Pin (cdc-p-1/p-2/p-3/p-4/p-5).
| Device ID | K964989 |
| 510k Number | K964989 |
| Device Name: | CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-13 |
| Decision Date | 1997-04-02 |
| Summary: | summary |