The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Genicon Trocar.
Device ID | K982472 |
510k Number | K982472 |
Device Name: | GENICON TROCAR |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
Contact | Gary W Haberland |
Correspondent | Gary W Haberland GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-15 |
Decision Date | 1999-02-04 |
Summary: | summary |