510(k) K946187 ยท EIA Unit, Operative Dental
SPIRIT II AND SPIRIT TREATMENT CENTER
| Applicant | Pelton & Crane Co., Charlotte NC, US |
| Decision | Substantially Equivalent, Mar 1, 1995 |
| Received | Dec 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2012 | Pelton & Crane Company Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273
Product Usage:
The intended use of the dental operative unit is for supplying pow Terminated |
EIA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.