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FDA 510(k)

MOLINEA UNDERPADS

K-Number: K843402 · 1984-09-07

Decision Date1984-09-07
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MOLINEA UNDERPADS is the device name listed in this FDA 510(k) record. The listed applicant is Paul Hartmann Corp.. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K843402. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLINEA UNDERPADS?

MOLINEA UNDERPADS is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Paul Hartmann Corp.. The 510(k) number is K843402.

When did MOLINEA UNDERPADS receive FDA 510(k) clearance?

MOLINEA UNDERPADS received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843402.

Who is the listed applicant for MOLINEA UNDERPADS?

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

What is the FDA product code for MOLINEA UNDERPADS?

The FDA product code for MOLINEA UNDERPADS is KME.

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 Paul Hartmann 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: KME)

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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