ICASE


Device Classification Name

case, contact lens

510(k) Number K021248
Device Name ICASE
Original Applicant
IKEEPS, INC.
p.o. box 4341
crofton, 
MD 
21114

Original Contact e. j. smith
Regulation Number 886.5928
Classification Product Code
LRX  
Date Received 04/19/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No