The following data is part of a premarket notification filed by Lead-lok, Inc. with the FDA for Gold Gators.
| Device ID | K903729 |
| 510k Number | K903729 |
| Device Name: | GOLD GATORS |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | James W Healy |
| Correspondent | James W Healy LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-09-14 |