Talymed Suspension
K-Number: K160695 · 2016-12-06
ApplicantMarine Polymer Technologies, Inc.
Decision Date2016-12-06
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Talymed Suspension is a medical device manufactured by Marine Polymer Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-06 under approval number K160695. 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 Talymed Suspension?
Talymed Suspension is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Marine Polymer Technologies, Inc.. The 510(k) number is K160695.
When was Talymed Suspension approved by the FDA?
Talymed Suspension received FDA 510(k) clearance on 2016-12-06, under approval number K160695.
What company makes Talymed Suspension?
Talymed Suspension is manufactured by Marine Polymer Technologies, Inc..
What is the FDA product code for Talymed Suspension?
The FDA product code for Talymed Suspension is FRO. This falls under the Anesthesiology category.
Related Devices (Code: FRO)
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
K153565DONASORB SILVER WOUND DRESSINGVirchow Biotech Pvt, Ltd.
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.