N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL

FDA Premarket Approval P880024 S002

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

DeviceN-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL
Generic NameLens, Contact (other Material) - Daily
ApplicantTHE LAGADO CORP.
Date Received1993-03-05
Decision Date1994-02-24
PMAP880024
SupplementS002
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address THE LAGADO CORP. 2890 South Tejon St. englewood, CO 80110

Supplemental Filings

Supplement NumberDateSupplement Type
P880024Original Filing
S003 1993-03-05 Normal 180 Day Track
S002 1993-03-05 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00858174006027 P880024 002
00858174006010 P880024 002

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