510(k) K220891
- Device
- Kahook Dual Blade Glide (KDB Glide)
- Applicant
- New World Medical, Inc.
- 510(k) number
- K220891
- Product code
- QUQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-17
- Date received
- 2022-03-28
- Regulation
- 878.4400
- Classification name
- Knife, Intraocular Pressure Lowering
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Victor Arellano
- Address
- 10763 Edison Ct. Rancho Cucamonga CA US 91730 91730
FDA Registration Numbers#
- 1000125279
- 2032521
- 3013023969