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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 K973915
Device Name INFLATABLE POSITIONING CUSHIONS
Applicant
Kci New Technologies, Inc.
3440 E. Houston
San Antonio,  TX  78219
Applicant Contact JUDITH A HARBOUR
Correspondent
Kci New Technologies, Inc.
3440 E. Houston
San Antonio,  TX  78219
Correspondent Contact JUDITH A HARBOUR
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/14/1997
Decision Date 11/10/1997
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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