COBE PPD 1.9

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 1.9.

Pre-market Notification Details

Device IDK812336
510k NumberK812336
Device Name:COBE PPD 1.9
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 Received1981-08-18
Decision Date1981-08-31

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