The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Entriport.
Device ID | K142464 |
510k Number | K142464 |
Device Name: | Entriport |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Contact | Anna D'lima |
Correspondent | Anna D'lima CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-02 |
Decision Date | 2015-03-05 |
Summary: | summary |