510(k) K971078
K971078 is an FDA 510(k) premarket notification submitted by Medjet, Inc. for the device "HYDROBRUSH (TM) KERATOME". The FDA issued a decision of Substantially Equivalent on January 23, 1998. The device falls under product code HQS (Burr, Corneal, Ac-Powered), a Class I device regulated under 21 CFR 886.4070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1998
- Date Received
- March 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burr, Corneal, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type