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510(k) K981169

Device
RONDEX CPR ISO-SHIELD
Applicant
RONDEX PRODUCTS, INC.
510(k) number
K981169
Product code
LYM  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-19
Date received
1998-03-30
Regulation
510(k) Premarket Notification
Classification name
Device, Cpr Assist
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GENE R BALDWIN
Address
P.O. Box # 1829 Rockford IL US 61110 61110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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