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FDA 510(k)

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

K-Number: K152876 · 2016-01-08

ApplicantTni Manufacturing, Inc.
Decision Date2016-01-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is a medical device manufactured by Tni Manufacturing, Inc.. It received FDA 510(k) clearance on 2016-01-08 under approval number K152876. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Tni Manufacturing, Inc.. The 510(k) number is K152876.

When was LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM approved by the FDA?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM received FDA 510(k) clearance on 2016-01-08, under approval number K152876.

What company makes LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is manufactured by Tni Manufacturing, Inc..

What is the FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

The FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is DQY.

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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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