The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed: Stat 2 And Stat 2 Pumpette Extension Sets And Masterflow And Masterflow Pumpette Primary Sets.
| Device ID | K964844 |
| 510k Number | K964844 |
| Device Name: | CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-03-24 |