Cleared Traditional

K933686 - LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE
(FDA 510(k) Clearance)

K933686 · Look, Inc. · General & Plastic Surgery
Dec 1993
Decision
147d
Days
Class 2
Risk

K933686 is an FDA 510(k) clearance for the LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 23, 1993, 147 days after receiving the submission on July 29, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.

Submission Details

510(k) Number K933686 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date December 23, 1993
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4495

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