IVORY PREMIUM RUBBER DAM

Dam, Rubber

COLUMBUS DENTAL MFG. CO.

The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Ivory Premium Rubber Dam.

Pre-market Notification Details

Device IDK863816
510k NumberK863816
Device Name:IVORY PREMIUM RUBBER DAM
ClassificationDam, Rubber
Applicant COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis,  MO  63188
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis,  MO  63188
Product CodeEIE  
CFR Regulation Number872.6300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-30
Decision Date1986-10-27

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