Cleared Traditional

K950529 - PEREGRINE DIFFUSION LIGHT PIPE
(FDA 510(k) Clearance)

K950529 · Peregrine Surgical , Ltd. · Ophthalmic

Jun 1995

Decision

120d

Days

Class 2

Risk

K950529 is an FDA 510(k) clearance for the PEREGRINE DIFFUSION LIGHT PIPE, a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on June 7, 1995, 120 days after receiving the submission on February 7, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number	K950529 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 1995
Decision Date	June 07, 1995
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement