SPIRIT S1/S2

Unit, Operative Dental

PELTON & CRANE CO.

The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Spirit S1/s2.

Pre-market Notification Details

Device IDK962071
510k NumberK962071
Device Name:SPIRIT S1/S2
ClassificationUnit, Operative Dental
Applicant PELTON & CRANE CO. 11727 FRUEHAUF DR. Charlotte,  NC  28243
ContactKristi Kunkel
CorrespondentKristi Kunkel
PELTON & CRANE CO. 11727 FRUEHAUF DR. Charlotte,  NC  28243
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-28
Decision Date1996-08-06

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