510(k) K971134
K971134 is an FDA 510(k) premarket notification submitted by John Branch for the device "VISTA EYESHOWER". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code LXQ (Cup, Eye), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1997
- Date Received
- March 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Eye
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type