FDA.report

510(k) K952414

Device
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
Applicant
ACACIA LABORATORIES, INC.
510(k) number
K952414
Product code
KNY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-23
Date received
1995-05-23
Regulation
876.5130
Classification name
Accessories, Catheter, G-u
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BEN WALTHALL
Address
1719 S. Grand Ave. Santa Ana CA US 92705 92705

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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