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510(k) K853126

Device
BIO PACK MODEL 200
Applicant
BIO MEDICUS, INC.
510(k) number
K853126
Product code
MOX  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-11
Date received
1985-07-25
Regulation
510(k) Premarket Notification
Classification name
Batteries, Rechargeable, For Class 2 Devices
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
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN R DALPEE
Address
9600 W. 76 St. Eden Prairie MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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