K780375 is an FDA 510(k) clearance for the PAVLIK HARNESS. This device is classified as a Splint, Abduction, Congenital Hip Dislocation (Class I - General Controls, product code IOZ).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978, 7 days after receiving the submission on March 8, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3665.
| 510(k) Number | K780375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1978 |
| Decision Date | March 15, 1978 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOZ — Splint, Abduction, Congenital Hip Dislocation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3665 |