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FDA 510(k) Applications Submitted by ROBERT WOLFERT PH.D
FDA 510(k) Number
Submission Date
Device Name
Applicant
K980637
02/19/1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
IMPLEX CORP.
K980781
03/02/1998
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
IMPLEX CORP.
K072599
09/14/2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
DIADEXUS, INC.
K980762
02/27/1998
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
PALL CORP.
K960993
03/12/1996
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
PALL BIOMEDICAL PRODUCTS CO.
K110831
03/25/2011
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
SONITUS MEDICAL INC
K050067
01/12/2005
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
FIRST QUALITY HYGIENIC, INC.
K140077
01/13/2014
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
ALBAAD LTD.
K963034
08/05/1996
FEMTEX GENTLE TOUCH TAMPONS
FIRST QUALITY HYGIENIC, INC.
K964323
10/30/1996
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
FEN DENTAL MFG., INC.
K964380
11/04/1996
LC-250 INFRARED LIGHT COAGULATOR
NK-OPTIK AMERICA
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