REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS— 510(k) K062435

Substantially Equivalent

Spire Biomedical, Inc.

FDA 510(k) clearance K062435 for REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS, Substantially Equivalent on 2006-12-05. Applicant: Spire Biomedical, Inc..

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code NFK
Advisory panel: Gastroenterology, Urology
Date received: 2006-08-21
Decision date: 2006-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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