510(k) K132291

NAMSA CHEMICAL PROCESS by North American Science Assoc., Inc. — Product Code JOJ

K132291 is an FDA 510(k) premarket notification submitted by North American Science Assoc., Inc. for the device "NAMSA CHEMICAL PROCESS". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. North American Science Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2014
Date Received
July 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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