The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Soft-tip Suction/irrigation Cannulae.
| Device ID | K950170 |
| 510k Number | K950170 |
| Device Name: | CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. 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 | 1995-01-17 |
| Decision Date | 1995-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405011368 | K950170 | 000 |