COBE PPD 1.3L, #18-520-009

Dialyzer, Parallel Flow

COBE LABORATORIES, INC.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Ppd 1.3l, #18-520-009.

Pre-market Notification Details

Device IDK820694
510k NumberK820694
Device Name:COBE PPD 1.3L, #18-520-009
ClassificationDialyzer, Parallel Flow
Applicant COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJG  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-12
Decision Date1982-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.