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FDA 510(k)

PYLORISET DRY

K-Number: K942974 · 1995-04-05

Decision Date1995-04-05
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORISET DRY is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Div. Orion Corp.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K942974. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYLORISET DRY?

PYLORISET DRY is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Orion Diagnostica, Div. Orion Corp.. The 510(k) number is K942974.

When did PYLORISET DRY receive FDA 510(k) clearance?

PYLORISET DRY received FDA 510(k) clearance on 1995-04-05, under 510(k) number K942974.

Who is the listed applicant for PYLORISET DRY?

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

What is the FDA product code for PYLORISET DRY?

The FDA product code for PYLORISET DRY is LYR.

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.

Other records listing Orion Diagnostica, Div. 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.

Related Devices (Code: LYR)

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.

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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