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FDA 510(k)

MASKY

K-Number: K973542 · 1998-02-10

ApplicantPressing DI Monticelli Rag. Stefano
Decision Date1998-02-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MASKY is the device name listed in this FDA 510(k) record. The listed applicant is Pressing DI Monticelli Rag. Stefano. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K973542. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASKY?

MASKY is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Pressing DI Monticelli Rag. Stefano. The 510(k) number is K973542.

When did MASKY receive FDA 510(k) clearance?

MASKY received FDA 510(k) clearance on 1998-02-10, under 510(k) number K973542.

Who is the listed applicant for MASKY?

The FDA 510(k) record lists Pressing DI Monticelli Rag. Stefano as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASKY?

The FDA product code for MASKY is EBI.

Related Clinical Trials

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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Other records listing Pressing DI Monticelli Rag. Stefano 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.

K955946ACETAL DENTAL/PREFORMED CLASP

Related Devices (Code: EBI)

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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