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510(k) K944481

Device
THE HEART PROTECTOR
Applicant
GARAN SCIENTIFIC, INC.
510(k) number
K944481
Product code
NXB  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-10
Date received
1994-09-13
Regulation
890.5050
Classification name
Dispenser, Solid Medication
Medical specialty
Physical Medicine
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GARY STERN
Address
P.O. Box 1396 Morristown NJ US 07960 07960

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882731TAB PAKDynex Trading Co.1988-12-14
K833311NITROGLYCERINE CONTAINERApothecary Products, Inc.1984-02-04

Legacy Summary#

summary

FDA Review#

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