FDA 510(k) Application Details - K050350

Device Classification Name Perimeter, Automatic, Ac-Powered

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510(K) Number K050350
Device Name Perimeter, Automatic, Ac-Powered
Applicant NOTAL VISION, INC.
15825 SHADY GROVE RD., STE 30
ROCKVILLE, MD 20850 US
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Contact RICHARD E LIPPMAN
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Regulation Number 886.1605

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Classification Product Code HPT
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Date Received 02/11/2005
Decision Date 04/29/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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