The following data is part of a premarket notification filed by Huestis Machine Corp. with the FDA for Huestis Flexi-holder.
| Device ID | K792721 |
| 510k Number | K792721 |
| Device Name: | HUESTIS FLEXI-HOLDER |
| Classification | Cassette, Radiographic Film |
| Applicant | HUESTIS MACHINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-31 |
| Decision Date | 1980-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085007700701 | K792721 | 000 |
| 00850077007125 | K792721 | 000 |
| 00850077007118 | K792721 | 000 |
| 00850077007101 | K792721 | 000 |
| 00850077007095 | K792721 | 000 |
| 00850077007088 | K792721 | 000 |
| 00850077007071 | K792721 | 000 |
| 00850077007040 | K792721 | 000 |