Cleared Traditional

SOFT LENS FOLDING BLOCK

K891487 · Western Medical Products, Inc. · Ophthalmic

Aug 1989

Decision

151d

Days

Class 1

Risk

About This 510(k) Submission

K891487 is an FDA 510(k) clearance for the SOFT LENS FOLDING BLOCK, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Western Medical Products, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 1989, 151 days after receiving the submission on March 17, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K891487 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1989
Decision Date	August 15, 1989
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—