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510(k) K790639

Device
Gonad Shield
Applicant
THE MOCHLETT LABORATORIES, INC.
510(k) number
K790639
Product code
KPY
Decision
Substantially Equivalent (SESE)
Decision date
1979-04-23
Date received
1979-03-30
Regulation
892.6500
Classification name
Shield, Protective, Personnel
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110900DISPOSABLE THYROID COLLARBloxr Corporation2011-06-24
K962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.1996-10-01
K954456THERMOPLASTIC SHIELDMedtec, Inc.1995-12-21
K954146UTK-DTE AUTILARY SHIELDMallinckrodt Medical1995-12-06
K953610AUKULYTEAukland Medical Plastics, Inc.1995-09-26
K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.1995-04-10
K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , Ltd.1995-04-03
K940539STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORMStandard Imaging, Inc.1994-03-16
K934206MAVIG ANGIO SHIELD MODELS 6290 & 6272F. Walter Hanel GmbH1993-10-07
K912326DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERSDavis Lead Aprons, Inc.1992-03-18
K912327DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.Davis Lead Aprons, Inc.1992-03-18
K912378DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERSDavis Lead Aprons, Inc.1992-03-18
K900970RADIATION PROTECTION GLASSESInfab Corp.1990-05-01
K896511DU PONT XENOLITE(TM) RADIATION PROTECTION APPARELE.I. Dupont DE Nemours & Co., Inc.1989-12-22
K896289RADIATION PROTECTION APRONInfab Corp.1989-12-14