FDA.report

510(k) K953541

Device
INSTANT COLDGEL
Applicant
PRISM TECHNOLOGIES, INC.
510(k) number
K953541
Product code
IMD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-05
Date received
1995-07-28
Regulation
890.5710
Classification name
Pack, Hot Or Cold, Disposable
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
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
HOWARD M HOLSTEIN
Address
555 Thirteenth St. NW Washington DC US 20004 20004

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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