510(k) K771132

KENWOOD BIOLOGICAL STEOILIZ. INDICATOR by Will Ross Co. — Product Code FRC

K771132 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "KENWOOD BIOLOGICAL STEOILIZ. INDICATOR". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Will Ross Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1977
Date Received
June 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type