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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K960840
Device Name C.E. VASCULAR MACHINE
Applicant
C.E. Diagnosis, Inc.
One Mulberry St.
East Ellijay,  GA  30539
Applicant Contact CARLOS A SELMONOSKY
Correspondent
C.E. Diagnosis, Inc.
One Mulberry St.
East Ellijay,  GA  30539
Correspondent Contact CARLOS A SELMONOSKY
Regulation Number868.1760
Classification Product Code
JEH  
Date Received02/29/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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