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FDA 510(k)

SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004

K-Number: K083886 · 2009-03-23

ApplicantSimpler One Stop
Decision Date2009-03-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 is the device name listed in this FDA 510(k) record. The listed applicant is Simpler One Stop. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K083886. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004?

SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Simpler One Stop. The 510(k) number is K083886.

When did SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 receive FDA 510(k) clearance?

SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 received FDA 510(k) clearance on 2009-03-23, under 510(k) number K083886.

Who is the listed applicant for SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004?

The FDA 510(k) record lists Simpler One Stop as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004?

The FDA product code for SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 is DZE.

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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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