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510(k) K940152

Device
CAMERA COVER WITH TEAR TIP
Applicant
HYDRO-MED PRODUCTS, INC.
510(k) number
K940152
Product code
FEM  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-28
Date received
1994-01-03
Regulation
876.1500
Classification name
Accessories, Photographic, For Endoscope (exclude Light Sources)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BONNIE BEASLEY
Address
2930 Ladybird Ln. Dallas TX US 75220 75220

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812201PHOTOGRAPHIC EQUIPMENTReznik Instruments1981-10-19
K812542POLAROID INSTANT ENDOCAMERAPolaroid Corp.1981-10-19
K792512POLAROID LAND CAMERA FOR ENDOSCOPYPolaroid Corp.1979-12-20

Legacy Summary#

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FDA Review#

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