TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS— 510(k) K112087
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K112087 for TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS, Substantially Equivalent on 2012-10-15. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code KCT
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view all- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
Data sourced from openFDA. This site is unofficial and independent of the FDA.