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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, electroconductive
510(k) Number K970694
Device Name MODEL 1700, HYDRO PREP
Applicant
PHYSIOMETRIX, INC.
FIVE BILLERICA PARK,
101 BILLERICA AVE.
NORTH BILLERICA,  MA  01862
Applicant Contact DAWN E FRAZER
Correspondent
PHYSIOMETRIX, INC.
FIVE BILLERICA PARK,
101 BILLERICA AVE.
NORTH BILLERICA,  MA  01862
Correspondent Contact DAWN E FRAZER
Regulation Number882.1275
Classification Product Code
GYB  
Date Received02/25/1997
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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