FDA.reportPublic FDA data

510(k) K853663

Device
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
Applicant
TRAVENOL LABORATORIES, S.A.
510(k) number
K853663
Product code
LPZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-09
Date received
1985-09-03
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
Third party reviewed
No

Applicant Contact#

Contact
JOHN BRDA
Address
Deerfield IL US 60015 60015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021702CRYOBAG, MODEL CBOrigen Biomedical, Inc.2002-08-06
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases