The following data is part of a premarket notification filed by Devon Safety Products, Inc. with the FDA for Devon Standard Syringe, Hypodermic Needle And Insulin Syringe.
| Device ID | K052551 |
| 510k Number | K052551 |
| Device Name: | DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | DEVON SAFETY PRODUCTS, INC. 1100 FIRST AVE., SUITE 100 King Of Prussia, PA 19406 |
| Contact | Barry L Berler |
| 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 | 2005-09-16 |
| Decision Date | 2005-09-30 |
| Summary: | summary |