Data / Medical devices / United States / Dgh-Koi, Inc.
Dgh-Koi, Inc.: FDA-registered device maker in Carlisle, PA, United States, 1 510(k) clearance
Dgh-Koi, Inc. is registered with the FDA (registration 2529996) in Carlisle, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 9, 1983. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2529996
- FEI number
- 1000161143
- Address
- 218 N College St, Carlisle, PA, United States, 17013
- Owner or operator
- DGH TECHNOLOGY, INC. (2522950)
- Roles
- Manufacturer
- First device listed
- October 19, 2009
- Registered through
- 2026
- Brand names listed
- Diamond Knife, Knife, Ophthalmic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 9, 1983 | K830366 | DIAMOND KNIFE | HNN | Substantially Equivalent | Koi, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 9, 1983. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.