MINI FLEX COIL— 510(k) K961628

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K961628 for MINI FLEX COIL, Substantially Equivalent on 1996-09-05. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant
W. L. Gore & Associates, Inc.
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Phoenix, AZ, US
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