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FDA 510(k)

Renovo Life Hard Carbon Coated Drill Bit

K-Number: K151661 · 2016-01-15

ApplicantRenovo Life, LLC
Decision Date2016-01-15
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovo Life Hard Carbon Coated Drill Bit is the device name listed in this FDA 510(k) record. The listed applicant is Renovo Life, LLC. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151661. The device is classified under product code HTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renovo Life Hard Carbon Coated Drill Bit?

Renovo Life Hard Carbon Coated Drill Bit is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Renovo Life, LLC. The 510(k) number is K151661.

When did Renovo Life Hard Carbon Coated Drill Bit receive FDA 510(k) clearance?

Renovo Life Hard Carbon Coated Drill Bit received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151661.

Who is the listed applicant for Renovo Life Hard Carbon Coated Drill Bit?

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

What is the FDA product code for Renovo Life Hard Carbon Coated Drill Bit?

The FDA product code for Renovo Life Hard Carbon Coated Drill Bit is HTW.

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Other records listing Renovo Life, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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