The following data is part of a premarket notification filed by Ortho Kinetics Corp. with the FDA for Affirm Smart Releasable Force Module And Compliance Science System.
| Device ID | K982088 |
| 510k Number | K982088 |
| Device Name: | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM |
| 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 | 1998-06-15 |
| Decision Date | 1998-09-04 |