FDA 510(k) Application Details - K991840

Device Classification Name Tonometer, Manual

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510(K) Number K991840
Device Name Tonometer, Manual
Applicant BERNARD B. FRESCO
40 SAINT CLAIR AVE EAST 303
TORONTO, ONTARIO M4T 1M9 CA
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Contact BERNARD B FRESCO
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Regulation Number 886.1930

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Classification Product Code HKY
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Date Received 05/28/1999
Decision Date 03/20/2000
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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