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FDA 510(k)

GRAFT DELIVERY SYSTEM MODEL SA-6115

K-Number: K100754 · 2010-06-09

ApplicantMicromedics, Inc.
Decision Date2010-06-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GRAFT DELIVERY SYSTEM MODEL SA-6115 is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2010-06-09 under 510(k) number K100754. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAFT DELIVERY SYSTEM MODEL SA-6115?

GRAFT DELIVERY SYSTEM MODEL SA-6115 is a medical device that received FDA 510(k) clearance on 2010-06-09. The listed applicant is Micromedics, Inc.. The 510(k) number is K100754.

When did GRAFT DELIVERY SYSTEM MODEL SA-6115 receive FDA 510(k) clearance?

GRAFT DELIVERY SYSTEM MODEL SA-6115 received FDA 510(k) clearance on 2010-06-09, under 510(k) number K100754.

Who is the listed applicant for GRAFT DELIVERY SYSTEM MODEL SA-6115?

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

What is the FDA product code for GRAFT DELIVERY SYSTEM MODEL SA-6115?

The FDA product code for GRAFT DELIVERY SYSTEM MODEL SA-6115 is FMF.

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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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