The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Pop-n-lok Syringe.
| Device ID | K946219 |
| 510k Number | K946219 |
| Device Name: | POP-N-LOK SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 622 S. MILL ST. Lewisville, TX 75057 |
| Contact | Tod S Hewitt |
| Correspondent | Tod S Hewitt RETRACTABLE TECHNOLOGIES, INC. 622 S. MILL ST. Lewisville, TX 75057 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-21 |
| Decision Date | 1995-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703130228 | K946219 | 000 |
| 00613703103123 | K946219 | 000 |
| 00613703103222 | K946219 | 000 |
| 00613703103321 | K946219 | 000 |
| 00613703103420 | K946219 | 000 |
| 00613703103529 | K946219 | 000 |
| 00613703103628 | K946219 | 000 |
| 00613703103727 | K946219 | 000 |
| 00613703103826 | K946219 | 000 |
| 00613703103925 | K946219 | 000 |
| 00613703130129 | K946219 | 000 |
| 00613703103024 | K946219 | 000 |