SOLCART B

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

B. BRAUN MEDIZINTECHNOLOGIE GMBH

The following data is part of a premarket notification filed by B. Braun Medizintechnologie Gmbh with the FDA for Solcart B.

Pre-market Notification Details

Device IDK072760
510k NumberK072760
Device Name:SOLCART B
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant B. BRAUN MEDIZINTECHNOLOGIE GMBH 901 MARCON BOULEVARD Allentown,  PA  18109 -9341
ContactTracy Maddock
CorrespondentTracy Maddock
B. BRAUN MEDIZINTECHNOLOGIE GMBH 901 MARCON BOULEVARD Allentown,  PA  18109 -9341
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-28
Decision Date2008-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046963332730 K072760 000
04046963332709 K072760 000

Trademark Results [SOLCART B]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLCART B
SOLCART B
77194577 3713720 Live/Registered
B.BRAUN AVITUM AG
2007-05-31

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