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FDA 510(k)

BONE MARROW BIOPSY TRAY

K-Number: K941846 · 1994-05-18

ApplicantKormed, Inc.
Decision Date1994-05-18
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE MARROW BIOPSY TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Kormed, Inc.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K941846. 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 BONE MARROW BIOPSY TRAY?

BONE MARROW BIOPSY TRAY is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Kormed, Inc.. The 510(k) number is K941846.

When did BONE MARROW BIOPSY TRAY receive FDA 510(k) clearance?

BONE MARROW BIOPSY TRAY received FDA 510(k) clearance on 1994-05-18, under 510(k) number K941846.

Who is the listed applicant for BONE MARROW BIOPSY TRAY?

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

What is the FDA product code for BONE MARROW BIOPSY TRAY?

The FDA product code for BONE MARROW BIOPSY TRAY is LRO.

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.

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Other records listing Kormed, Inc. 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.

K944044CHIBA STYLE BIOPSY NEEDLE

Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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