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FDA 510(k) Application Details - K083377
Device Classification Name
Tonometer, Ac-Powered
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510(K) Number
K083377
Device Name
Tonometer, Ac-Powered
Applicant
ACCUTOME ULTRASOUND, INC.
263 GREAT VALLEY PARKWAY
MALVERN, PA 19355 US
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Contact
BRIAN T.S. BARRETT
Other 510(k) Applications for this Contact
Regulation Number
886.1930
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Classification Product Code
HKX
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More FDA Info for this Product Code
Date Received
11/14/2008
Decision Date
07/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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