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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name replacement, ossicular prosthesis, total
510(k) Number K042503
Device Name KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Applicant Contact DAGMAR MASER
Correspondent
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Correspondent Contact DAGMAR MASER
Regulation Number874.3495
Classification Product Code
ETA  
Date Received09/15/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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