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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clinical Sample Concentrator
510(k) Number K943965
Device Name VIVAPORE 10
Applicant
Vivascience, Inc.
P.O. Box 2240
Acton,  MA  01720
Applicant Contact DENNIS B HUNT
Correspondent
Vivascience, Inc.
P.O. Box 2240
Acton,  MA  01720
Correspondent Contact DENNIS B HUNT
Regulation Number862.2310
Classification Product Code
JJH  
Date Received07/28/1994
Decision Date 04/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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