S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE— 510(k) K023229

Name: FDA 510(k) clearance K023229
Creator: U.S. Food and Drug Administration
Published: 2002-12-13

Substantially Equivalent

American Mammographics, Inc.

FDA 510(k) clearance K023229 for S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE, Substantially Equivalent on 2002-12-13. Applicant: American Mammographics, Inc.. Device class: 2.

Clearance details

Applicant: American Mammographics, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2002-09-27
Decision date: 2002-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chattanooga, TN, US

Download summary PDF View on FDA.gov ↗

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