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FDA 510(k), K200125, Thermoforming Sheet Materials
FDA 510(k), K200125, Thermoforming Sheet Materials
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$49.00 USD
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Sale price
$49.00 USD
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per
510(K) Number: K200125
Device Name: Thermoforming Sheet Materials
Manufacturer: Hans-Peter Kopp
Device Classification Name: Mouthguard, Prescription
Regulation Number: MQC
Classification Product Code: KXA
Date Received: 01/21/2020
Decision Date: 10/28/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Thermoforming Sheet Materials
Manufacturer: Hans-Peter Kopp
Device Classification Name: Mouthguard, Prescription
Regulation Number: MQC
Classification Product Code: KXA
Date Received: 01/21/2020
Decision Date: 10/28/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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