The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Gleeson Flo Vac & Selectone S/i Cannulae Model 60-6001, 6002, 6005.
| Device ID | K960562 |
| 510k Number | K960562 |
| Device Name: | GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Contact | Ira D Duesler |
| Correspondent | Ira D Duesler CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40653405040720 | K960562 | 000 |
| 40653405040713 | K960562 | 000 |
| 40653405011553 | K960562 | 000 |
| 40653405011515 | K960562 | 000 |
| 40653405011508 | K960562 | 000 |
| 20653405011481 | K960562 | 000 |
| 20653405011405 | K960562 | 000 |