The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Jarit Take-apart Endoscopic Instruments.
| Device ID | K103726 |
| 510k Number | K103726 |
| Device Name: | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Contact | Stephanie Sheesley |
| Correspondent | Stephanie Sheesley INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2012-02-08 |
| Summary: | summary |