K961454 is an FDA 510(k) clearance for the AMMI MAGNI-GUARD. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by American Medical Mfg., Inc. (Chatsworth, US). The FDA issued a Cleared decision on July 25, 1996, 101 days after receiving the submission on April 15, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K961454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1996 |
| Decision Date | July 25, 1996 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |