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FDA 510(k) Applications Submitted by DONNA WARD
FDA 510(k) Number
Submission Date
Device Name
Applicant
K990585
02/23/1999
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K990652
03/01/1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K981327
04/13/1998
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K991853
06/01/1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K982249
06/26/1998
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K983832
10/30/1998
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K994254
12/17/1999
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI
K960021
01/02/1996
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
CALCITEK, INC.
K970127
01/14/1997
EDOSSEOUS DENTAL IMPLANT
SULZER CALCITEK, INC.
K962106
05/31/1996
SPLINE DENTAL IMPLANT SYSTEMS
CALCITEK, INC.
K962576
07/01/1996
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
CALCITEK, INC.
K943604
07/25/1994
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
CALCITEK, INC.
K955619
12/11/1995
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
CALCITEK, INC.
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