Submission Details
| 510(k) Number | K842650 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 10, 1984 |
| Decision Date | August 10, 1984 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K842650 is an FDA 510(k) clearance for the WALL GRAB BARS 98130-98136, a Aid, Transfer (Class I — General Controls, product code IKX), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 31 days after receiving the submission on July 10, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.
| 510(k) Number | K842650 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 10, 1984 |
| Decision Date | August 10, 1984 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKX — Aid, Transfer |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5050 |