LASIK EYE DRAPE
Trade Name
LASIK EYE DRAPE
Device Classification Name
Drape, Surgical
510(k) Number
K042977
Regulation Number
878.4370
Applicant
ODYSSEY MEDICAL, INC. 5828 shelby oaks dr. memphis, TN 38134
Contact
Ivan Harlan
Product Code
KKX
Date Received
10/28/2004
Decision Date
05/10/2005
Decision
substantially equivalent (SE)
Classification Advisory Committee
General & Plastic Surgery
Review Advisory Committee
General Hospital
Statement/Summary/Purged Status
Summary only
Summary
Summary
Type
Traditional
Reviewed by Third Party
No
Expedited Review
No
