Cleared Traditional

BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA

K860648 · Precision Instruments, Inc. · Ophthalmic

Mar 1986

Decision

33d

Days

Class 1

Risk

About This 510(k) Submission

K860648 is an FDA 510(k) clearance for the BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA, a Trephine, Manual, Ophthalmic (Class I — General Controls, product code HRH), submitted by Precision Instruments, Inc. (Grand Blanc, US). The FDA issued a Cleared decision on March 25, 1986, 33 days after receiving the submission on February 20, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K860648 FDA.gov
FDA Decision	Cleared SN
Date Received	February 20, 1986
Decision Date	March 25, 1986
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—