OP-3 (TM) RGP CONTACT LENS

FDA Premarket Approval P920045 S001

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.

Pre-market Approval Supplement Details

DeviceOP-3 (TM) RGP CONTACT LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantSTELLAR CONTACT LENS, INC.
Date Received1994-01-27
Decision Date1994-02-24
PMAP920045
SupplementS001
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address STELLAR CONTACT LENS, INC. 8131 Tripp Avenue skokie, IL 60076

Supplemental Filings

Supplement NumberDateSupplement Type
P920045Original Filing
S001 1994-01-27 Normal 180 Day Track

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