510(k) K040901
K040901 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "STERITEC EMU-GRAPH, MODEL NO. CI 131/US". The FDA issued a decision of Substantially Equivalent on Sep 9, 2004. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products, Inc. has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2004
- Date Received
- Apr 7, 2004
- 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
- 510(k)