The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Comed Trogard(tm) Blunt Tip Trocar/sleeve.
Device ID | K933456 |
510k Number | K933456 |
Device Name: | COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
Contact | Martin P Forte |
Correspondent | Martin P Forte CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-14 |
Decision Date | 1993-11-02 |