Cleared Traditional

BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON

K864520 · Precision Instruments, Inc. · Ophthalmic

Jan 1987

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K864520 is an FDA 510(k) clearance for the BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON, 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 January 20, 1987, 64 days after receiving the submission on November 17, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K864520 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1986
Decision Date	January 20, 1987
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—