KPY — Shield, Protective, Personnel Class I

FDA Device Classification

Classification Details

Product Code
KPY
Device Class
Class I
Regulation Number
892.6500
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K110900bloxr corporationDISPOSABLE THYROID COLLARJune 24, 2011
K962622medtecINTRA-ORAL THERMOPLASTIC SHIELDOctober 1, 1996
K954456medtecTHERMOPLASTIC SHIELDDecember 21, 1995
K954146mallinckrodt medicalUTK-DTE AUTILARY SHIELDDecember 6, 1995
K953610aukland medical plasticsAUKULYTESeptember 26, 1995
K951004kenex2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)April 10, 1995
K951003kenexKENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)April 3, 1995
K940539standard imagingSTAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORMMarch 16, 1994
K934206f. walter hanelMAVIG ANGIO SHIELD MODELS 6290 & 6272October 7, 1993
K912326davis lead apronsDAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERSMarch 18, 1992
K912327davis lead apronsDAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.March 18, 1992
K912378davis lead apronsDAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERSMarch 18, 1992
K900970infabRADIATION PROTECTION GLASSESMay 1, 1990
K896511e.i. dupont de nemours and coDU PONT XENOLITE(TM) RADIATION PROTECTION APPARELDecember 22, 1989
K896289infabRADIATION PROTECTION APRONDecember 14, 1989
K871502cis-usPERSONNEL PROTECTIVE SHIELDMay 8, 1987
K844160syncor intlVENTIBOXDecember 17, 1984
K811677medi-physics inc. dba nycomed amersham imagingKRYPTON CARTJuly 2, 1981
K811068g.d. searle andBYPASS COILMay 27, 1981
K810095moti enterprisesMOTI APRONFebruary 12, 1981