The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Enternal Y Extension Set Recorder.
| Device ID | K840656 |
| 510k Number | K840656 |
| Device Name: | ENTERNAL Y EXTENSION SET RECORDER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CORPAK MEDSYSTEMS 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770459940 | K840656 | 000 |
| 10350770456703 | K840656 | 000 |