STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION

FDA Premarket Approval P890067 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

DeviceSTERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantSTERIDYNE LABORATORIES, INC.
Date Received1990-08-16
Decision Date1991-01-18
PMAP890067
SupplementS001
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address STERIDYNE LABORATORIES, INC. 3238 Canyon Lake Dr. los Angeles, CA 90068

Supplemental Filings

Supplement NumberDateSupplement Type
P890067Original Filing
S005 1993-12-15 Normal 180 Day Track
S004 1993-11-30 Normal 180 Day Track
S003
S002
S001 1990-08-16 Normal 180 Day Track

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