The following data is part of a premarket notification filed by Ortho Kinetics Corp. with the FDA for Releasable Force Module.
| Device ID | K980151 |
| 510k Number | K980151 |
| Device Name: | RELEASABLE FORCE MODULE |
| 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 | 1998-01-16 |
| Decision Date | 1998-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190730007377 | K980151 | 000 |
| 00190730007360 | K980151 | 000 |
| 00190707000608 | K980151 | 000 |
| 00190707000493 | K980151 | 000 |
| 00190707000486 | K980151 | 000 |
| 00190707000479 | K980151 | 000 |
| 00190707000462 | K980151 | 000 |