K841156 is an FDA 510(k) clearance for the VANTAGE E. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984, 25 days after receiving the submission on March 19, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K841156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1984 |
| Decision Date | April 13, 1984 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |