FDA.report

510(k) K813488

Device
CATHETER REGULAR
Applicant
ACCURATE SURGICAL INSTRUMENTS CO.
510(k) number
K813488
Product code
FJS  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-31
Date received
1981-12-01
Regulation
876.5630
Classification name
Catheter, Peritoneal, Long-term Indwelling
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

Contact
ACCURATE SURGICAL INSTRUMENTS CO
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

Related GUDID Devices

Primary DIBrandCompanyPublished
10884521056022ArgyleCovidien LP2015-10-12

Legacy Summary

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FDA Review

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