Submission Details
| 510(k) Number | K780181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K780181 is an FDA 510(k) clearance for the GLOVES, FLOOR, a Chair, Blood Donor (Class I — General Controls, product code FML), submitted by Tillotson Rubber Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978, 18 days after receiving the submission on February 3, 1978. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6140.
| 510(k) Number | K780181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FML — Chair, Blood Donor |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6140 |