The following data is part of a premarket notification filed by Confluent Surgical,inc with the FDA for Covidien Extended Tip Applicator.
| Device ID | K091315 |
| 510k Number | K091315 |
| Device Name: | COVIDIEN EXTENDED TIP APPLICATOR |
| Classification | Syringe, Piston |
| Applicant | CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
| Contact | Sean Reynolds |
| Correspondent | Sean Reynolds CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780000167 | K091315 | 000 |
| 10381780000150 | K091315 | 000 |
| 30381780000147 | K091315 | 000 |