FDA.report

510(k) K823296

Device
PC-205 TENCKHOFF CATHETER ROD OBTURATOR
Applicant
MEDIGROUP
510(k) number
K823296
Product code
FKX  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-26
Date received
1982-11-05
Regulation
876.5630
Classification name
System, Peritoneal, Automatic Delivery
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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00884450277478Peritoneal DialysisMerit Medical Systems, Inc.2016-09-16
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Legacy Summary

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FDA Review

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