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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSAULFON PW-70 A&B
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantLOMBART LENSES, LTD.
1215 BOISSEVAIN AVE.
NORFOLK, VA 23507
PMA NumberP840031
Supplement NumberS001
Date Received04/01/1985
Decision Date04/17/1985
Withdrawal Date 11/07/2007
Product Code LPM 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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