510(k) K081094

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 by Olympic Medical Corp. — Product Code MEC

K081094 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500". The FDA issued a decision of Substantially Equivalent on June 20, 2008. The device falls under product code MEC (Disinfector, Medical Devices), a Class II device regulated under 21 CFR 880.6992. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
April 17, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfector, Medical Devices
Device Class
Class II
Regulation Number
880.6992
Review Panel
HO
Submission Type