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510(k) K021702

Device
CRYOBAG, MODEL CB
Applicant
ORIGEN BIOMEDICAL, INC.
510(k) number
K021702
Product code
LPZ  
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-06
Date received
2002-05-23
Regulation
510(k) Premarket Notification
Classification name
Container, Frozen Donor Tissue Storage
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD MARTIN
Address
9709-A Beck Cir. Austin TX US 78758 78758

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915471CRYOBAGJanus Biomedical, Inc.1994-03-02
K863872TAMPER HAMPERHydro-Med Products, Inc.1987-02-10
K861761ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGETravenol Laboratories, S.A.1986-08-28
K860511AMPU-PAKAmmerman Medical Enterprises, Inc.1986-08-04
K853663ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STORTravenol Laboratories, S.A.1986-04-09

Legacy Summary#

summary

FDA Review#

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