SMARTSUCTION HARMONY DEVICE

Pump, Portable, Aspiration (manual Or Powered)

HAEMONETICS CORP.

The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Smartsuction Harmony Device.

Pre-market Notification Details

Device IDK052626
510k NumberK052626
Device Name:SMARTSUCTION HARMONY DEVICE
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant HAEMONETICS CORP. 400 WOOD ROAD Braintree,  MA  02184 -9114
ContactGabriel J Muraca
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-09-23
Decision Date2005-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747016968 K052626 000
30812747017354 K052626 000
30812747017347 K052626 000
30812747017330 K052626 000

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