510(k) K990246

STERI-PAK LF BOWIE-DICK TEST PACK by Steritec Products Mfg Co, Inc. — Product Code JOJ

K990246 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERI-PAK LF BOWIE-DICK TEST PACK". The FDA issued a decision of Substantially Equivalent on Jun 10, 1999. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products Mfg Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 10, 1999
Date Received
Jan 26, 1999
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