DRYASOL ACID CONCENTRATE MIX

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

DIASOL, INC.

The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Dryasol Acid Concentrate Mix.

Pre-market Notification Details

Device IDK993212
510k NumberK993212
Device Name:DRYASOL ACID CONCENTRATE MIX
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant DIASOL, INC. 13212 RAYMER ST. North Hollywood,  CA  91605
ContactMonica Abeles
CorrespondentMonica Abeles
DIASOL, INC. 13212 RAYMER ST. North Hollywood,  CA  91605
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-24
Decision Date1999-10-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B467ACP453257510016 K993212 000
B467ACP452257520025 K993212 000
B467ACP452257510016 K993212 000
B467ACP451257510016 K993212 000
B467ACP362351020025 K993212 000
B467ACP362251020025 K993212 000
B467ACP362201020025 K993212 000
B467ACP352251010025 K993212 000

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