FDA 510(k) Application Details - K990044

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K990044
Device Name Accessories, Soft Lens Products
Applicant LOBOB LABORATORIES, INC.
2000 M ST. NW # 700
WASHINGTON, DC 20036-3307 US
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Contact DANIEL J MANELLI
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 01/06/1999
Decision Date 02/11/1999
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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