The following data is part of a premarket notification filed by Confluent Surgical,inc with the FDA for Confluent Surgical Micromyst Applicator And Air Pump, Models 20-5000, Ap-a-6063.
| Device ID | K050998 |
| 510k Number | K050998 |
| Device Name: | CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 |
| Classification | Syringe, Piston |
| Applicant | CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
| Contact | Eric P Ankerud |
| Correspondent | Eric P Ankerud CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-20 |
| Decision Date | 2005-06-15 |
| Summary: | summary |