FDA.report

510(k) K912715

Device
INSTANT WARM GEL PACK
Applicant
PRISM TECHNOLOGIES, INC.
510(k) number
K912715
Product code
IMD  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-02
Date received
1991-06-18
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
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHARLES F MANKER
Address
3111 N. Knox Ave. Chicago IL US 60641 60641

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
20888937025730WARMGEL INSTANT HEAT PACK - LargeCoopersurgical, Inc.2022-11-29
20888937025723WARMGEL INSTANT HEAT PACK - MediumCoopersurgical, Inc.2022-11-29
30888937020145fisherbrand Disposable Liquid Infant Heel WarmerCoopersurgical, Inc.2022-11-29
30888937020015fisherbrand Disposable Gel Infant Heel WarmerCoopersurgical, Inc.2022-11-29

Legacy Summary

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FDA Review

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