FDA 510(k) Application Details - K991620

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K991620
Device Name Accessories, Soft Lens Products
Applicant PFIZER, INC.
235 EAST 42ND ST.
NEW YORK, NY 10017 US
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Contact JOHN TOMASZEWSKI
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 05/11/1999
Decision Date 09/24/1999
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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