EYEFEEL OPHTHALMIC WARMER


Device Classification Name

pack, hot or cold, disposable

510(k) Number K021843
Device Name EYEFEEL OPHTHALMIC WARMER
Original Applicant
BIO-LIPID, INC.
1301 k street, n.w.
suite 1100
washington, 
DC 
20005

Original Contact david j bloch
Regulation Number 890.5710
Classification Product Code
IMD  
Date Received 06/05/2002
Decision Date 09/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No