FDA 510(k) Application Details - K974723

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K974723
Device Name Accessories, Soft Lens Products
Applicant BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact PAUL G STAPLETON
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 12/18/1997
Decision Date 03/10/1998
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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