K910515 is an FDA 510(k) clearance for the FREEDOM MARK III SURGICAL HELMET SYSTEM. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stackhouse Assoc. (Riverside, US). The FDA issued a Cleared decision on May 6, 1991, 90 days after receiving the submission on February 5, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K910515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1991 |
| Decision Date | May 06, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |