510(k) K954080 ยท HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
SODEM HIGH SPEED SYSTEM
| Applicant | Sodem Diffusion SA, North Attleboro MA, US |
| Decision | Substantially Equivalent, Oct 16, 1995 |
| Received | Aug 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954080
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.