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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K970992
Device Name PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
Applicant
Premier Dental Products Co.
3600 Horizon Dr.
P.O. Box 61574
King Of Prussia,  PA  19406
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
3600 Horizon Dr.
P.O. Box 61574
King Of Prussia,  PA  19406
Correspondent Contact WILLIAM J FREZEL
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/19/1997
Decision Date 06/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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