The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Nima (needleless Injectionsite Master Adapter) & I.v. Set.
| Device ID | K952852 |
| 510k Number | K952852 |
| Device Name: | NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CRITICAL DEVICE CORP. 499 NIBUS ST. Brea, CA 92621 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk 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 | 1995-06-21 |
| Decision Date | 1996-02-16 |