510(k) K931621 ยท HRX Arthroscope
ACUFEX PRO-PAC AND ISO-PAC
| Applicant | Acufex Microsurgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 21, 1994 |
| Received | Apr 2, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2003 | Smith & Nephew, Inc. Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile
Catalog Number: 014725 Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.