Cleared Traditional

HOSPITAL KIT EP 104

K922128 · Savoy Medical Supply Co., Inc. · General & Plastic Surgery
Mar 1993
Decision
321d
Days
Class 1
Risk

About This 510(k) Submission

K922128 is an FDA 510(k) clearance for the HOSPITAL KIT EP 104, a Instrument, Manual, Surgical, General Use (Class I — General Controls, product code MDM), submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 23, 1993, 321 days after receiving the submission on May 6, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K922128 FDA.gov
FDA Decision Cleared SESK
Date Received May 06, 1992
Decision Date March 23, 1993
Days to Decision 321 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MDM — Instrument, Manual, Surgical, General Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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