ERIKA CAPD PREP KIT #30-9501-5

System, Peritoneal, Automatic Delivery

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Capd Prep Kit #30-9501-5.

Pre-market Notification Details

Device IDK820179
510k NumberK820179
Device Name:ERIKA CAPD PREP KIT #30-9501-5
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant ERIKA, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-22
Decision Date1982-02-19

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