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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K961029
Device Name KILTEX PROBE COVER
Applicant
KILTEX CORP.
2064 KILLIAN RD.
AKRON,  OH  44312
Applicant Contact TIMOTHY J KILLIAN
Correspondent
KILTEX CORP.
2064 KILLIAN RD.
AKRON,  OH  44312
Correspondent Contact TIMOTHY J KILLIAN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/14/1996
Decision Date 07/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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