CELL SAVER 5 SYSTEM

Apparatus, Autotransfusion

HAEMONETICS CORP.

The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Cell Saver 5 System.

Pre-market Notification Details

Device IDK932890
510k NumberK932890
Device Name:CELL SAVER 5 SYSTEM
ClassificationApparatus, Autotransfusion
Applicant HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree,  MA  02184
ContactMatthew Nowland
CorrespondentMatthew Nowland
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 Received1993-06-14
Decision Date1994-01-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747016814 K932890 000
10812747016025 K932890 000
30812747016036 K932890 000
30812747016043 K932890 000
10812747016063 K932890 000
30812747016074 K932890 000
30812747016098 K932890 000
30812747016104 K932890 000
30812747016111 K932890 000
30812747016128 K932890 000
30812747016135 K932890 000
30812747016142 K932890 000
30812747016265 K932890 000
30812747016272 K932890 000
30812747016340 K932890 000
30812747016487 K932890 000
30812747015169 K932890 000

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