The following data is part of a premarket notification filed by Pinyons Medical Technology, Inc. with the FDA for Powrsyringe Injector.
| Device ID | K072318 |
| 510k Number | K072318 |
| Device Name: | POWRSYRINGE INJECTOR |
| Classification | Syringe, Piston |
| Applicant | PINYONS MEDICAL TECHNOLOGY, INC. 5010 HEUGA CT. Park City, UT 84098 |
| Contact | Shawn P Fojtik |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B090PWR101 | K072318 | 000 |