The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Patient Safe Luer Cap.
| Device ID | K101708 |
| 510k Number | K101708 |
| Device Name: | PATIENT SAFE LUER CAP |
| Classification | Syringe, Piston |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Contact | Rhonda Wells |
| Correspondent | Rhonda Wells RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2011-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703510228 | K101708 | 000 |