The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Trogard Electronic Trocar System.
Device ID | K954599 |
510k Number | K954599 |
Device Name: | CONMED TROGARD ELECTRONIC TROCAR SYSTEM |
Classification | Cannula, Surgical, 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 | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-03 |
Decision Date | 1995-11-27 |