COBE PPD .8

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 .8.

Pre-market Notification Details

Device IDK810066
510k NumberK810066
Device Name:COBE PPD .8
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 Received1981-01-13
Decision Date1981-06-09

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