510(k) K970992
K970992 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1997
- Date Received
- March 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type