LF Process Indicator Tape for Steam Sterilization
FDA 510(k) clearance K260181 · decided 2026-02-20
Clearance details
- K-number
- K260181
- Device name
- LF Process Indicator Tape for Steam Sterilization
- Applicant
- Intertape Polymer Group
- Decision
- Substantially Equivalent
- Date received
- 2026-01-21
- Decision date
- 2026-02-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.