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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plethysmograph, Impedance
510(k) Number K852238
Device Name IPG-300
Applicant
Thornton Associates, Inc.
1001 Twenty-Second St., NW
Washington,  DC  20037
Applicant Contact THOMAS M SUSMAN
Correspondent
Thornton Associates, Inc.
1001 Twenty-Second St., NW
Washington,  DC  20037
Correspondent Contact THOMAS M SUSMAN
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/23/1985
Decision Date 10/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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