FDA.report

510(k) K801386

Device
PRE-DENT SYSTEM OR PRE-DENT II
Applicant
PRE-DENT SYSTEM
510(k) number
K801386
Product code
KSS  
Decision
Substantially Equivalent (SESE)
Decision date
1980-07-14
Date received
1980-06-13
Regulation
864.9050
Classification name
Supplies, Blood-bank
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSS  

510(k)DeviceApplicantDecision date
K874436FLUID SAMPLING PACKU.S. Mfg. & Management, Inc.1988-01-05
K812892S/P SERUM DROPPER PIPETSAmerican Dade1981-10-27
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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