510(k) K012579 ยท NKX Needle, Phacoemulsification, Reprocessed
REPROCESSED PHACO TIPS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 8, 2001 |
| Received | Aug 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Phaco Tips
Model #'s:
ALC30RTS
ALC8065740806
ALC8065740809
ALC8065740837
ALC8065740839
ALC8065750852
ALC8065790020
ALC8065790022 and
ALLOPOR3020L
Intended use of this device is to assist in the auto Terminated |
NKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.