Cleared Traditional

SIL-MED WASTE FLUID DUMP BAG

K891471 · Sil-Med Corp. · General & Plastic Surgery
Aug 1989
Decision
153d
Days
Class 1
Risk

About This 510(k) Submission

K891471 is an FDA 510(k) clearance for the SIL-MED WASTE FLUID DUMP BAG, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on August 15, 1989, 153 days after receiving the submission on March 15, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K891471 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1989
Decision Date August 15, 1989
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDG — Chisel (osteotome)
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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