Cleared Traditional

STP SYSTEM PVA WITH ZINC

K963986 · Sage Products, Inc. · Microbiology
Nov 1996
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K963986 is an FDA 510(k) clearance for the STP SYSTEM PVA WITH ZINC, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on November 8, 1996, 35 days after receiving the submission on October 4, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K963986 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1996
Decision Date November 08, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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