Cleared Traditional

K801608 - MCCULLEY CONTINUOUS SUTURE TIGHTNER
(FDA 510(k) Clearance)

K801608 · Edward Weck, Inc. · Ophthalmic device

Aug 1980

Decision

28d

Days

Class 1

Risk

K801608 is an FDA 510(k) clearance for the MCCULLEY CONTINUOUS SUTURE TIGHTNER. This device is classified as a Spatula, Ophthalmic (Class I - General Controls, product code HND).

Submitted by Edward Weck, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1980, 28 days after receiving the submission on July 15, 1980.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K801608 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1980
Decision Date	August 12, 1980
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—