510(k) K991124
K991124 is an FDA 510(k) premarket notification submitted by Visijet, Inc. for the device "VISIJET HYDROKERATOME, MODEL 50". The FDA issued a decision of Substantially Equivalent on October 20, 2000. The device falls under product code MYD (Keratome, Water Jet), a Class I device regulated under 21 CFR 886.4370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2000
- Date Received
- April 2, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Keratome, Water Jet
- Device Class
- Class I
- Regulation Number
- 886.4370
- Review Panel
- OP
- Submission Type