The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Polyester Cardiotomy Reservoir, Filtered & Unfilte.
| Device ID | K844803 |
| 510k Number | K844803 |
| Device Name: | POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Gary R Webb |
| Correspondent | Gary R Webb ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250161 | K844803 | 000 |