The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Tygon Tubing.
| Device ID | K803277 |
| 510k Number | K803277 |
| Device Name: | TYGON TUBING |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-29 |
| Decision Date | 1981-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673978522477 | K803277 | 000 |
| 10673978522460 | K803277 | 000 |