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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K980235
Device Name REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
Applicant
Kci New Technologies, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Applicant Contact JUDITH A HARBOUR
Correspondent
Kci New Technologies, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Correspondent Contact JUDITH A HARBOUR
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/22/1998
Decision Date 04/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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