Cleared Traditional

NEEDLEHOLDER, MICROVASULAR 5 1/2

K780154 · Edward Weck, Inc. · Ophthalmic

Mar 1978

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K780154 is an FDA 510(k) clearance for the NEEDLEHOLDER, MICROVASULAR 5 1/2, a Needle, Ophthalmic Suturing (Class I — General Controls, product code HNM), submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978, 46 days after receiving the submission on January 30, 1978. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K780154 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1978
Decision Date	March 17, 1978
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—