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FDA 510(k)

'cottony' II TAPE, PLEDGETS

K-Number: K153089 · 2016-08-12

ApplicantTeleflexmedical, Inc.
Decision Date2016-08-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

'cottony' II TAPE, PLEDGETS is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-08-12 under approval number K153089. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 'cottony' II TAPE, PLEDGETS?

'cottony' II TAPE, PLEDGETS is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K153089.

When was 'cottony' II TAPE, PLEDGETS approved by the FDA?

'cottony' II TAPE, PLEDGETS received FDA 510(k) clearance on 2016-08-12, under approval number K153089.

What company makes 'cottony' II TAPE, PLEDGETS?

'cottony' II TAPE, PLEDGETS is manufactured by Teleflexmedical, Inc..

What is the FDA product code for 'cottony' II TAPE, PLEDGETS?

The FDA product code for 'cottony' II TAPE, PLEDGETS is GAT.

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Related Devices (Code: GAT)

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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.

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