HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

Apparatus, Autotransfusion

HAEMONETICS CORP.

The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cell Saver Elite Autotransfusion System.

Pre-market Notification Details

Device IDK101907
510k NumberK101907
Device Name:HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
ClassificationApparatus, Autotransfusion
Applicant HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree,  MA  02184
ContactGreg Calder
CorrespondentGreg Calder
HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree,  MA  02184
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-08
Decision Date2010-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747016630 K101907 000
30812747016586 K101907 000
30812747016579 K101907 000
30812747016562 K101907 000
30812747016555 K101907 000
30812747016548 K101907 000
30812747016531 K101907 000
30812747016524 K101907 000

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