The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Modular Design Electrosurgical Laproscopy Instruments.
Device ID | K934916 |
510k Number | K934916 |
Device Name: | CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
Contact | Ira D Duesler |
Correspondent | Ira D Duesler 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 | 1993-10-14 |
Decision Date | 1994-05-05 |