Cleared Traditional

K971064 - BAYERS BIMANUAL I/A HANDPIECES
(FDA 510(k) Clearance)

K971064 · Visioncare Devices, Inc. · Ophthalmic

Jun 1997

Decision

77d

Days

Class 2

Risk

K971064 is an FDA 510(k) clearance for the BAYERS BIMANUAL I/A HANDPIECES, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Visioncare Devices, Inc. (Redding, US). The FDA issued a Cleared decision on June 9, 1997, 77 days after receiving the submission on March 24, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K971064 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1997
Decision Date	June 09, 1997
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement