STERRAD STERILIZATION POUCH
FDA 510(k) clearance K951295 · decided 1995-05-19
Clearance details
- K-number
- K951295
- Device name
- STERRAD STERILIZATION POUCH
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 1995-03-22
- Decision date
- 1995-05-19
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contai recall (Z-1393-2011) | Advanced Sterilization Products | 2011-02-22 |