SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K960380
Device Name SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
Applicant
UNILENS CORP., USA
10431 72nd st. north
p.o. box 2530
largo, 
FL 
34647

Applicant Contact josepha bruno
Correspondent
UNILENS CORP., USA
10431 72nd st. north
p.o. box 2530
largo, 
FL 
34647

Correspodent Contact josepha bruno
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 01/26/1996
Decision Date 03/28/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No