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FDA 510(k)

IOPSY TRAY FOR SOFT TISSUE BIOPSY

K-Number: K771784 · 1977-11-30

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-11-30
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IOPSY TRAY FOR SOFT TISSUE BIOPSY 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 1977-11-30 under 510(k) number K771784. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOPSY TRAY FOR SOFT TISSUE BIOPSY?

IOPSY TRAY FOR SOFT TISSUE BIOPSY is a medical device that received FDA 510(k) clearance on 1977-11-30. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K771784.

When did IOPSY TRAY FOR SOFT TISSUE BIOPSY receive FDA 510(k) clearance?

IOPSY TRAY FOR SOFT TISSUE BIOPSY received FDA 510(k) clearance on 1977-11-30, under 510(k) number K771784.

Who is the listed applicant for IOPSY TRAY FOR SOFT TISSUE BIOPSY?

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 IOPSY TRAY FOR SOFT TISSUE BIOPSY?

The FDA product code for IOPSY TRAY FOR SOFT TISSUE BIOPSY is GAA.

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Related Devices (Code: GAA)

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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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