FDA 510(k) Application Details - K973217

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K973217
Device Name Accessories, Soft Lens Products
Applicant POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER, NY 14692 US
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Contact DOUGLAS J FORTUNATO
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 08/27/1997
Decision Date 11/24/1997
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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