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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K946187
Device Name SPIRIT II AND SPIRIT TREATMENT CENTER
Applicant
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Applicant Contact KRISTI KUNKEL
Correspondent
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Correspondent Contact KRISTI KUNKEL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/20/1994
Decision Date 03/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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