Dash-Topic Plus Cream
K-Number: K150914 · 2016-04-21
ApplicantFounders Science Group, LLC
Decision Date2016-04-21
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Dash-Topic Plus Cream is a medical device manufactured by Founders Science Group, LLC. It received FDA 510(k) clearance on 2016-04-21 under approval number K150914. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dash-Topic Plus Cream?
Dash-Topic Plus Cream is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Founders Science Group, LLC. The 510(k) number is K150914.
When was Dash-Topic Plus Cream approved by the FDA?
Dash-Topic Plus Cream received FDA 510(k) clearance on 2016-04-21, under approval number K150914.
What company makes Dash-Topic Plus Cream?
Dash-Topic Plus Cream is manufactured by Founders Science Group, LLC.
What is the FDA product code for Dash-Topic Plus Cream?
The FDA product code for Dash-Topic Plus Cream is FRO. This falls under the Anesthesiology category.
Other Devices by Founders Science Group, LLC
Related Devices (Code: FRO)
K160695Talymed SuspensionMarine Polymer Technologies, Inc.
K160872PolyPlex Wound DressingGlobal Health Solutions, LLC
K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc.
K152533Xonrid GelHelsinn Healthcare SA
K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation
K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.