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510(k) K811449

Device
HAEMONETICS 1000ML COMPONENT BAG
Applicant
HAEMONETICS CORP.
510(k) number
K811449
Product code
KSR  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-01
Date received
1981-05-22
Regulation
864.9100
Classification name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco Healthcare2003-12-08
K020753DEROYAL SURGICAL, UMBILICUPDeroyal2002-06-13
K810500BLOOD FREEZING BAGDelmed, Inc.1981-09-23
K810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.1981-09-23
K811523PLASMA FLEXTerumo America, Inc.1981-09-09
K810711HAEMONETICS 600 ML. COMPONENT BAGHaemonetics Corp.1981-05-08
K810313HAEMONETICS 1400 ML THERAPEUTIC BAGHaemonetics Corp.1981-03-31
K801082GAMBRO HEMOFREEZE-BAGGambro, Inc.1980-10-31
K801219PLASMAPOOLERNorth American Biologicals, Inc.1980-10-31
K792395PHARMAFLEX CRYOGENIC BAGPharmachem Corp.1980-02-26
K792185PIASMA SAFECry-O-Safe, Inc.1979-12-28
K791673EMPTY TRANSFER BAGDelmed, Inc.1979-10-23
K781811TRANSFER PAK 4R 9006Travenol Laboratories, S.A.1978-11-08
K780354CRYOCYTE PACKTravenol Laboratories, S.A.1978-06-14
K760952TERASAKI LYMPHOCYTE TRANSPORT KITDravon Medical, Inc.1977-01-17

Legacy Summary#

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FDA Review#

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