Cleared Traditional

PROCEDURE SPECIFIC KITS

K964168 · Sage Products, Inc. · General Hospital
Mar 1997
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K964168 is an FDA 510(k) clearance for the PROCEDURE SPECIFIC KITS, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on March 3, 1997, 137 days after receiving the submission on October 17, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K964168 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1996
Decision Date March 03, 1997
Days to Decision 137 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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