The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Quad Bipolar Laparoscopic Coagulating And Cutting Instrument.
| Device ID | K992186 |
| 510k Number | K992186 |
| Device Name: | QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-29 |
| Decision Date | 1999-07-30 |