K780227 is an FDA 510(k) clearance for the BANDAGE SPREADER BLOCK. This device is classified as a Accessories, Traction (Class I - General Controls, product code ILZ).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978, 34 days after receiving the submission on February 9, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5925.
| 510(k) Number | K780227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1978 |
| Decision Date | March 15, 1978 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILZ — Accessories, Traction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5925 |