510(k) K001056

OLYMPIC WARM-UP by Olympic Medical Corp. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2000
Date Received
April 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type