TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

Set, I.v. Fluid Transfer

BAXA CORP., SUB. OF COOK GROUP, INC.

The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Tubing Sets For Baxa Exacta-med Pharmacy Pump.

Pre-market Notification Details

Device IDK900585
510k NumberK900585
Device Name:TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
ClassificationSet, I.v. Fluid Transfer
Applicant BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood,  CO  80112
ContactMary Steggall
CorrespondentMary Steggall
BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood,  CO  80112
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-07
Decision Date1990-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412480072 K900585 000
50085412475726 K900585 000
50085412476525 K900585 000
50085412476549 K900585 000
50085412476556 K900585 000
50085412476709 K900585 000
50085412476860 K900585 000
50085412477003 K900585 000
50085412477201 K900585 000
50085412477218 K900585 000
50085412477225 K900585 000
50085412477232 K900585 000
50085412477249 K900585 000
50085412477256 K900585 000
50085412477263 K900585 000
50085412477270 K900585 000
55413765482590 K900585 000

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