ERGO SRS— 510(k) K031281

Substantially Equivalent

3D Line USA, Inc.

FDA 510(k) clearance K031281 for ERGO SRS, Substantially Equivalent on 2003-12-23. Applicant: 3D Line USA, Inc..

Clearance details

Applicant: 3D Line USA, Inc.
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2003-04-22
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owings Mills, MD, US

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