The following data is part of a premarket notification filed by Angiodynamics, Div. E-z-em, Inc. with the FDA for Angiography Syringe Kits.
| Device ID | K933846 |
| 510k Number | K933846 |
| Device Name: | ANGIOGRAPHY SYRINGE KITS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ANGIODYNAMICS, DIV. E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVE Glens Falls, NY 12801 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams ANGIODYNAMICS, DIV. E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVE Glens Falls, NY 12801 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1994-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17630039300880 | K933846 | 000 |
| 17630039300873 | K933846 | 000 |
| 37630039300334 | K933846 | 000 |
| 37630039300327 | K933846 | 000 |
| 37630039300310 | K933846 | 000 |
| 37630039300303 | K933846 | 000 |