The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Oneport Surgical Trocar System.
Device ID | K073009 |
510k Number | K073009 |
Device Name: | ONEPORT SURGICAL TROCAR SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Contact | Brian Killoran |
Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-10-25 |
Decision Date | 2007-12-07 |
Summary: | summary |