Cleared Traditional

K905703 - KRUPIN EYE VALVE WITH DISK
(FDA 510(k) Clearance)

K905703 · Hood Laboratories · Ophthalmic

Mar 1991

Decision

85d

Days

Class 2

Risk

K905703 is an FDA 510(k) clearance for the KRUPIN EYE VALVE WITH DISK, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 15, 1991, 85 days after receiving the submission on December 20, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number	K905703 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 1990
Decision Date	March 15, 1991
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—