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510(k) K874436

Device
FLUID SAMPLING PACK
Applicant
U.S. MFG. & MANAGEMENT, INC.
510(k) number
K874436
Product code
KSS  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-05
Date received
1987-10-28
Regulation
864.9050
Classification name
Supplies, Blood-bank
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANK J RAUSCHER
Address
287 S. Stoddard Ave. San Bernardino CA US 92401 92401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812892S/P SERUM DROPPER PIPETSAmerican Dade1981-10-27
K801386PRE-DENT SYSTEM OR PRE-DENT IIPre-Dent System1980-07-14
K801516PRE-DENT SYSTEM MODIFIEDPre-Dent System1980-07-14
K800736PRE-DENT SYSTEMPre-Dent System1980-04-24
K761303IMMU-SAL IMMUNOHEMATOLOGICAL SALINEDade, Baxter Travenol Diagnostics, Inc.1976-12-30

Legacy Summary#

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FDA Review#

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