HYDROBRUSH (TM) KERATOME
FDA 510(k) clearance K971078 · decided 1998-01-23
Clearance details
- K-number
- K971078
- Device name
- HYDROBRUSH (TM) KERATOME
- Applicant
- Medjet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-24
- Decision date
- 1998-01-23
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- HQS
- Device class
- 1
- Regulation number
- 886.4070
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.