510(k) K924681

GLUTARALDEHYDE MONITORS by Pymah Corp. — Product Code JOJ

K924681 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "GLUTARALDEHYDE MONITORS". The FDA issued a decision of Substantially Equivalent on November 17, 1993. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Pymah Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1993
Date Received
September 16, 1992
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