The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed Mixing And Delivery Kit.
| Device ID | K142535 |
| 510k Number | K142535 |
| Device Name: | ConMed Mixing And Delivery Kit |
| Classification | Syringe, Piston |
| Applicant | CONMED CORPORATION 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Dionne Sanders |
| Correspondent | Dionne Sanders CONMED CORPORATION 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-09 |
| Decision Date | 2015-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854080658 | K142535 | 000 |