The following data is part of a premarket notification filed by Telos Medical Corp. with the FDA for Lab-site Safety Needle.
| Device ID | K905018 |
| 510k Number | K905018 |
| Device Name: | LAB-SITE SAFETY NEEDLE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
| Contact | TIMOTHY J TALCOTT |
| Correspondent | TIMOTHY J TALCOTT TELOS MEDICAL CORP. 2044 WEST 11TH ST. KEENE, CA 91786 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-16 |