EXPANDACELL INJECTO-PAK— 510(k) K962133

Name: FDA 510(k) clearance K962133
Creator: U.S. Food and Drug Administration
Published: 1996-08-01

Substantially Equivalent

Shippert Medical Technologies Corp.

FDA 510(k) clearance K962133 for EXPANDACELL INJECTO-PAK, Substantially Equivalent on 1996-08-01. Applicant: Shippert Medical Technologies Corp.. Device class: 1.

Clearance details

Applicant: Shippert Medical Technologies Corp.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1996-06-03
Decision date: 1996-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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