The following data is part of a premarket notification filed by Physician Industries, Inc. with the FDA for Physician Industries' Durameter Syringe.
| Device ID | K033739 |
| 510k Number | K033739 |
| Device Name: | PHYSICIAN INDUSTRIES' DURAMETER SYRINGE |
| Classification | Syringe, Piston |
| Applicant | PHYSICIAN INDUSTRIES, INC. 2203 WEST ALEXANDER Salt Lake City, UT 84119 |
| Contact | Brian Baker |
| Correspondent | Brian Baker PHYSICIAN INDUSTRIES, INC. 2203 WEST ALEXANDER Salt Lake City, UT 84119 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-07-12 |
| Summary: | summary |