The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Secure Safety Insert.
| Device ID | K945825 |
| 510k Number | K945825 |
| Device Name: | SECURE SAFETY INSERT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SYNCOR INTL. CORP. 20001 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Don Reich |
| Correspondent | Don Reich SYNCOR INTL. CORP. 20001 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-04-10 |