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FDA 510(k) Application Details - K974408
Device Classification Name
Lenses, Soft Contact, Daily Wear
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510(K) Number
K974408
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
BIOCOMPATIBLES EYEWEAR, INC.
1215 BOISSEVAIN AVE.
NORFOLK, VA 23507 US
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Contact
LISA HAHN
Other 510(k) Applications for this Contact
Regulation Number
886.5925
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Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/1997
Decision Date
04/16/1998
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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