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FDA 510(k)

TRIMED STERILE PRODUCT

K-Number: K091156 · 2009-07-15

ApplicantTriMed, Inc.
Decision Date2009-07-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIMED STERILE PRODUCT is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2009-07-15 under 510(k) number K091156. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMED STERILE PRODUCT?

TRIMED STERILE PRODUCT is a medical device that received FDA 510(k) clearance on 2009-07-15. The listed applicant is TriMed, Inc.. The 510(k) number is K091156.

When did TRIMED STERILE PRODUCT receive FDA 510(k) clearance?

TRIMED STERILE PRODUCT received FDA 510(k) clearance on 2009-07-15, under 510(k) number K091156.

Who is the listed applicant for TRIMED STERILE PRODUCT?

The FDA 510(k) record lists TriMed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIMED STERILE PRODUCT?

The FDA product code for TRIMED STERILE PRODUCT is HRS.

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Other records listing TriMed, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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