The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Modified Schneider Shiley Inflation Syringes.
| Device ID | K875324 |
| 510k Number | K875324 |
| Device Name: | MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES |
| Classification | Injector And Syringe, Angiographic |
| Applicant | SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Ann H Morrissey |
| Correspondent | Ann H Morrissey SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-03-25 |