The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed 7/8mm Gasket Reducer For Use With Trogard(tm) Trocar Sleeve.
| Device ID | K946235 |
| 510k Number | K946235 |
| Device Name: | CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-02-13 |