510(k) K191741
K191741 is an FDA 510(k) premarket notification submitted by Intertape Polymer, Inc. for the device "Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape". The FDA issued a decision of Substantially Equivalent on Aug 2, 2019. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 2019
- Date Received
- Jul 1, 2019
- Clearance Type
- Special
- 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)