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FDA 510(k)

RECONSTITUTION ACCESSOREIS

K-Number: K950861 · 1995-05-26

ApplicantOrganon, Inc.
Decision Date1995-05-26
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RECONSTITUTION ACCESSOREIS is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K950861. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECONSTITUTION ACCESSOREIS?

RECONSTITUTION ACCESSOREIS is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Organon, Inc.. The 510(k) number is K950861.

When did RECONSTITUTION ACCESSOREIS receive FDA 510(k) clearance?

RECONSTITUTION ACCESSOREIS received FDA 510(k) clearance on 1995-05-26, under 510(k) number K950861.

Who is the listed applicant for RECONSTITUTION ACCESSOREIS?

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

What is the FDA product code for RECONSTITUTION ACCESSOREIS?

The FDA product code for RECONSTITUTION ACCESSOREIS is FPK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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