FDA.report

510(k) K850214

Device
STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
Applicant
ACCURATE SURGICAL INSTRUMENTS CO.
510(k) number
K850214
Product code
FJS  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-26
Date received
1985-01-22
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
ROTHMAN ROTHMAN
Address
590 Richmond St. W. Toronto Canado M5v 1y9 CA M5V 1Y9 M5V 1Y9

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
10884521004313ArgyleCovidien LP2015-10-12

Legacy Summary

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FDA Review

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