The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Trogard Trocar Dialating Trocar System.
Device ID | K961175 |
510k Number | K961175 |
Device Name: | TROGARD TROCAR DIALATING TROCAR SYSTEM |
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 | 1996-03-25 |
Decision Date | 1996-04-05 |