The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-aspirating Syringe, Miltex Lightweight.
| Device ID | K083796 |
| 510k Number | K083796 |
| Device Name: | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT |
| Classification | Syringe, Cartridge |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Jennifer J Bosley |
| Correspondent | Jennifer J Bosley MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-03-09 |
| Summary: | summary |