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FDA 510(k)

MAMEX DC MG11

K-Number: K881505 · 1988-06-10

ApplicantOrion Corp.
Decision Date1988-06-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMEX DC MG11 is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K881505. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMEX DC MG11?

MAMEX DC MG11 is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Orion Corp.. The 510(k) number is K881505.

When did MAMEX DC MG11 receive FDA 510(k) clearance?

MAMEX DC MG11 received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881505.

Who is the listed applicant for MAMEX DC MG11?

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

What is the FDA product code for MAMEX DC MG11?

The FDA product code for MAMEX DC MG11 is IZH.

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Other records listing Orion Corp. 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K874040MAMEX DC S SL10/MG14

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Related Devices (Code: IZH)

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

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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