K103210 is an FDA 510(k) clearance for the TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on June 6, 2011, 217 days after receiving the submission on November 1, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K103210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2010 |
| Decision Date | June 06, 2011 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |