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Syringe, Piston

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK170033
510k NumberBK170033
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationSyringe, Piston
Applicant Baxter Healthcare Corporation 32650 North Wilson Rd Round Lake,  IL  60073
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-04-04
Decision Date2017-07-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412600036 BK170033 0
20085412600028 BK170033 0
20085412600042 BK170033 000
50085412600036 BK170033 000
20085412600028 BK170033 000

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