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FDA 510(k)

ESSTECH PS ASPHERIC

K-Number: K942186 · 1994-07-28

Decision Date1994-07-28
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ESSTECH PS ASPHERIC is the device name listed in this FDA 510(k) record. The listed applicant is Szabocsik and Assoc.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K942186. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSTECH PS ASPHERIC?

ESSTECH PS ASPHERIC is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Szabocsik and Assoc.. The 510(k) number is K942186.

When did ESSTECH PS ASPHERIC receive FDA 510(k) clearance?

ESSTECH PS ASPHERIC received FDA 510(k) clearance on 1994-07-28, under 510(k) number K942186.

Who is the listed applicant for ESSTECH PS ASPHERIC?

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

What is the FDA product code for ESSTECH PS ASPHERIC?

The FDA product code for ESSTECH PS ASPHERIC is LPL.

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 Szabocsik and Assoc. 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: LPL)

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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