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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K991549
Device Name EMBOSPHERE MICROSPHERES
Applicant
BIOSPHERE MEDICAL
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
BIOSPHERE MEDICAL
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received05/03/1999
Decision Date 04/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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