FDA 510(k), K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
FDA 510(k), K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
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$149.00 USD
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$149.00 USD
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510(K) Number: K151123
Device Name: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Manufacturer: Wenying Zhu
Device Classification Name: Dental Barriers And Sleeves
Regulation Number: PEM
Classification Product Code: 04/28/2015
Date Received: 03/03/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Manufacturer: Wenying Zhu
Device Classification Name: Dental Barriers And Sleeves
Regulation Number: PEM
Classification Product Code: 04/28/2015
Date Received: 03/03/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental