510(k) K971078
- Device
- HYDROBRUSH (TM) KERATOME
- Applicant
- MEDJET, INC.
- 510(k) number
- K971078
- Product code
- HQS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-23
- Date received
- 1997-03-24
- Regulation
- 886.4070
- Classification name
- Burr, Corneal, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- EUGENE GORDON
- Address
- 1090 King Georges Post, #301 Edison NJ US 08837 08837
FDA Registration Numbers
- 8040278
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases