STERIDYNE DYNASPRAY

FDA Premarket Approval P860050 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 DYNASPRAY
Generic NameAccessories, Soft Lens Products
ApplicantOPTOPICS LABORATORIES CORP.
Date Received1987-05-21
Decision Date1987-11-17
PMAP860050
SupplementS001
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OPTOPICS LABORATORIES CORP. p.o. Box 210 fairton, NJ 08320-0210

Supplemental Filings

Supplement NumberDateSupplement Type
P860050Original Filing
S007 1990-01-26 Normal 180 Day Track
S006 1988-07-25 Normal 180 Day Track
S005 1987-12-14 Normal 180 Day Track
S004
S003
S002 1987-03-30 Normal 180 Day Track
S001 1987-05-21 Normal 180 Day Track

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