Cleared Traditional

SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE

K872906 · American Silk Sutures, Inc. · General & Plastic Surgery
Aug 1987
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K872906 is an FDA 510(k) clearance for the SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE, a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 11, 1987, 18 days after receiving the submission on July 24, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872906 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1987
Decision Date August 11, 1987
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GEA — Cannula, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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