The following data is part of a premarket notification filed by Ortho Kinetics Corp. with the FDA for New Gear Releasable Headgear.
| Device ID | K940410 |
| 510k Number | K940410 |
| Device Name: | NEW GEAR RELEASABLE HEADGEAR |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ORTHO KINETICS CORP. 1611A SOUTH MELROSE DRIVE, SUITE 16 Vista, CA 92083 |
| Contact | Steven O Luse |
| Correspondent | Steven O Luse ORTHO KINETICS CORP. 1611A SOUTH MELROSE DRIVE, SUITE 16 Vista, CA 92083 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D80723300021 | K940410 | 000 |
| 00190707005030 | K940410 | 000 |
| 00190707005047 | K940410 | 000 |
| 00190707005054 | K940410 | 000 |
| 00190707005078 | K940410 | 000 |
| 00190707005085 | K940410 | 000 |
| 00190707005092 | K940410 | 000 |
| 00190707005108 | K940410 | 000 |
| 00190707005115 | K940410 | 000 |
| 00190707005122 | K940410 | 000 |
| 00190707005023 | K940410 | 000 |
| 00190707004804 | K940410 | 000 |
| 00190707004798 | K940410 | 000 |
| D80723300031 | K940410 | 000 |
| D80723400021 | K940410 | 000 |
| D80723400031 | K940410 | 000 |
| 10817713022246 | K940410 | 000 |
| 10817713022253 | K940410 | 000 |
| 00190707000455 | K940410 | 000 |
| 00190707000578 | K940410 | 000 |
| 00190707000585 | K940410 | 000 |
| 00190707000592 | K940410 | 000 |
| 00190707005405 | K940410 | 000 |
| 00190707005412 | K940410 | 000 |
| 00190730007322 | K940410 | 000 |
| 00190730007339 | K940410 | 000 |
| 00190730007346 | K940410 | 000 |
| 00304040018415 | K940410 | 000 |
| 00304040018422 | K940410 | 000 |
| 00304040018439 | K940410 | 000 |
| 00304040018446 | K940410 | 000 |
| 00304040018453 | K940410 | 000 |
| 00304040018460 | K940410 | 000 |
| 00190730007315 | K940410 | 000 |
| 00190707005528 | K940410 | 000 |
| 00190707005511 | K940410 | 000 |
| 00190707005429 | K940410 | 000 |
| 00190707005436 | K940410 | 000 |
| 00190707005443 | K940410 | 000 |
| 00190707005450 | K940410 | 000 |
| 00190707005467 | K940410 | 000 |
| 00190707005474 | K940410 | 000 |
| 00190707005481 | K940410 | 000 |
| 00190707005498 | K940410 | 000 |
| 00190707005504 | K940410 | 000 |
| 00304040018477 | K940410 | 000 |