The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Laborie Fiberoptic Pressure Sensor & Interface.
| Device ID | K853059 |
| 510k Number | K853059 |
| Device Name: | LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River, NY 10965 |
| Contact | Corrine M Ambrosino |
| Correspondent | Corrine M Ambrosino TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River, NY 10965 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1986-01-10 |