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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameN-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL
Classification Namelens, contact (other material) - daily
Regulation Number886.5916
ApplicantNEEFE OPTICAL SUPPLY
PMA NumberP880024
Supplement NumberS002
Date Received03/05/1993
Decision Date02/24/1994
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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