Cleared Traditional

VISITEC PRECISE-POINT

K942234 · Visitec Co. · General & Plastic Surgery
Jul 1994
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K942234 is an FDA 510(k) clearance for the VISITEC PRECISE-POINT, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on July 12, 1994, 64 days after receiving the submission on May 9, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.

Submission Details

510(k) Number K942234 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1994
Decision Date July 12, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAP — Suture, Nonabsorbable, Silk
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5030

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