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FDA 510(k)

NEOTIS; NEOTIS 50

K-Number: K130953 · 2013-07-15

ApplicantSbm Sciences For Bio Materials
Decision Date2013-07-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEOTIS; NEOTIS 50 is the device name listed in this FDA 510(k) record. The listed applicant is Sbm Sciences For Bio Materials. It received FDA 510(k) clearance on 2013-07-15 under 510(k) number K130953. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOTIS; NEOTIS 50?

NEOTIS; NEOTIS 50 is a medical device that received FDA 510(k) clearance on 2013-07-15. The listed applicant is Sbm Sciences For Bio Materials. The 510(k) number is K130953.

When did NEOTIS; NEOTIS 50 receive FDA 510(k) clearance?

NEOTIS; NEOTIS 50 received FDA 510(k) clearance on 2013-07-15, under 510(k) number K130953.

Who is the listed applicant for NEOTIS; NEOTIS 50?

The FDA 510(k) record lists Sbm Sciences For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOTIS; NEOTIS 50?

The FDA product code for NEOTIS; NEOTIS 50 is MQV.

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Official Source

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