PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
FDA 510(k) clearance K970992 · decided 1997-06-17
Clearance details
- K-number
- K970992
- Device name
- PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-19
- Decision date
- 1997-06-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- King Of Prussia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument recall (Z-0215-05) | Premier Dental Products Co | 2004-11-20 |
| Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrumen recall (Z-0216-05) | Premier Dental Products Co | 2004-11-20 |