GLYCACOR— 510(k) K980888

Substantially Equivalent

Exocell, Inc.

FDA 510(k) clearance K980888 for GLYCACOR, Substantially Equivalent on 1998-08-13. Applicant: Exocell, Inc.. Device class: 2.

Clearance details

Applicant: Exocell, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1998-03-09
Decision date: 1998-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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