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FDA 510(k)

E-Z PREP(R) TRAY WITH HIBICLENS(R)

K-Number: K935483 · 1994-02-09

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1994-02-09
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-Z PREP(R) TRAY WITH HIBICLENS(R) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1994-02-09 under 510(k) number K935483. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z PREP(R) TRAY WITH HIBICLENS(R)?

E-Z PREP(R) TRAY WITH HIBICLENS(R) is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K935483.

When did E-Z PREP(R) TRAY WITH HIBICLENS(R) receive FDA 510(k) clearance?

E-Z PREP(R) TRAY WITH HIBICLENS(R) received FDA 510(k) clearance on 1994-02-09, under 510(k) number K935483.

Who is the listed applicant for E-Z PREP(R) TRAY WITH HIBICLENS(R)?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Z PREP(R) TRAY WITH HIBICLENS(R)?

The FDA product code for E-Z PREP(R) TRAY WITH HIBICLENS(R) is LRO.

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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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