Submission Details
| 510(k) Number | K241542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 31, 2024 |
| Decision Date | June 27, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
3M? Attest? Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)
Jun 2024
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K241542 is an FDA 510(k) clearance for the 3M? Attest? Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on June 27, 2024, 27 days after receiving the submission on May 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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