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510(k) K970992

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS by Premier Dental Products Co. — Product Code GEH

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

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