PAFLUFOCON C AND E DAILY CONTACT LENS


the company

Device Classification Name

lens, contact (other material) – daily

510(k) Number K002845
Device Name PAFLUFOCON C AND E DAILY CONTACT LENS
Original Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa, 
AZ 
85204

Original Contact william e meyers
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 09/12/2000
Decision Date 12/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No