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FDA 510(k)

SLANT/FIN HEPA CLEAR

K-Number: K953536 · 1995-10-30

ApplicantAmcor, Ltd.
Decision Date1995-10-30
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SLANT/FIN HEPA CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Amcor, Ltd.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K953536. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLANT/FIN HEPA CLEAR?

SLANT/FIN HEPA CLEAR is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Amcor, Ltd.. The 510(k) number is K953536.

When did SLANT/FIN HEPA CLEAR receive FDA 510(k) clearance?

SLANT/FIN HEPA CLEAR received FDA 510(k) clearance on 1995-10-30, under 510(k) number K953536.

Who is the listed applicant for SLANT/FIN HEPA CLEAR?

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

What is the FDA product code for SLANT/FIN HEPA CLEAR?

The FDA product code for SLANT/FIN HEPA CLEAR is FRF.

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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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