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510(k) K935146

Device
DISPOSABLE STETHOSCOPE HEAD COVER
Applicant
MODERN MEDICAL DEVICES, INC.
510(k) number
K935146
Product code
BZS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-11
Date received
1993-10-28
Regulation
868.1930
Classification name
Stethoscope Head
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LESLIE E MANZANILLA
Address
42307 Osgood Rd. Suite N Fremont CA US 94539 94539

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930118STETSKINSNova Diversified Concepts1993-03-26
K801050SUPRA SCOPEWarner-Lambert Co.1980-05-14

Legacy Summary#

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FDA Review#

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