The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Nitrospray Plus And Premier Nitrospray Lite Plus.
| Device ID | K970992 |
| 510k Number | K970992 |
| Device Name: | PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | PREMIER DENTAL PRODUCTS CO. 3600 HORIZON DR. P.O. BOX 61574 King Of Prussia, PA 19406 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL PRODUCTS CO. 3600 HORIZON DR. P.O. BOX 61574 King Of Prussia, PA 19406 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-06-17 |
| Summary: | summary |