510(k) K970992 ยท GEH Unit, Cryosurgical, Accessories
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
| Applicant | Premier Dental Products Co., King Of Prussia PA, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Mar 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2004 | Premier Dental Products Co Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument Terminated |
GEH | None listed |
| Nov 20, 2004 | Premier Dental Products Co Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.