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FDA 510(k)

SERIES XE, SERIES SE, SERIES TE

K-Number: K971350 · 1997-06-04

ApplicantMicro-Mega Societe Anonyme
Decision Date1997-06-04
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SERIES XE, SERIES SE, SERIES TE is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Mega Societe Anonyme. It received FDA 510(k) clearance on 1997-06-04 under 510(k) number K971350. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES XE, SERIES SE, SERIES TE?

SERIES XE, SERIES SE, SERIES TE is a medical device that received FDA 510(k) clearance on 1997-06-04. The listed applicant is Micro-Mega Societe Anonyme. The 510(k) number is K971350.

When did SERIES XE, SERIES SE, SERIES TE receive FDA 510(k) clearance?

SERIES XE, SERIES SE, SERIES TE received FDA 510(k) clearance on 1997-06-04, under 510(k) number K971350.

Who is the listed applicant for SERIES XE, SERIES SE, SERIES TE?

The FDA 510(k) record lists Micro-Mega Societe Anonyme as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES XE, SERIES SE, SERIES TE?

The FDA product code for SERIES XE, SERIES SE, SERIES TE is EGS.

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Other records listing Micro-Mega Societe Anonyme 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.

K103123APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)K081268SONIC AIR MM1500 + (MID), MODEL 50400014K042171AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232K961275SIRIUS 10, 10L, 40, 40LK961235SIRIUS 180, 180L, 230, 230LK961494SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE

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Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220346Lotus Prophy AngleAjk Engineering, Inc.

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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