510(k) K885125

KRUPIN EYE VALVE W/SCLERAL BUCKLE by Hood Laboratories — Product Code KYF

K885125 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "KRUPIN EYE VALVE W/SCLERAL BUCKLE". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
December 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type