510(k) K781979 ยท HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
SURGAIRTOME TWO
| Applicant | American Sterilizer Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 20, 1978 |
| Received | Nov 27, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2008 | Linvatec Corp. ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773 Terminated |
GFF | None listed |
| Oct 23, 2004 | Linvatec Corp. Ultra Power Burs, Sterile, Single-Use. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.