Cleared Traditional

IOL IMPLANTATION FORCEPS

K883197 · D & D Surgical · Ophthalmic

Aug 1988

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K883197 is an FDA 510(k) clearance for the IOL IMPLANTATION FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by D & D Surgical (Renton, US). The FDA issued a Cleared decision on August 22, 1988, 25 days after receiving the submission on July 28, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K883197 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1988
Decision Date	August 22, 1988
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—