The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Golden Retrievers Or Silver Retrievers.
| Device ID | K800444 |
| 510k Number | K800444 |
| Device Name: | GOLDEN RETRIEVERS OR SILVER RETRIEVERS |
| Classification | Probe |
| Applicant | INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXB |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-03-05 |