510(k) K024293
K024293 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "BOWIE-DICK MINI PAK, MODEL BD 115". The FDA issued a decision of Substantially Equivalent on Aug 11, 2003. 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
- Aug 11, 2003
- Date Received
- Dec 24, 2002
- Clearance Type
- Abbreviated
- 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)