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FDA 510(k)

BIOPSY KIT

K-Number: K892389 · 1989-07-17

ApplicantI M, Inc.
Decision Date1989-07-17
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1989-07-17 under 510(k) number K892389. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BIOPSY KIT?

BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1989-07-17. The listed applicant is I M, Inc.. The 510(k) number is K892389.

When did BIOPSY KIT receive FDA 510(k) clearance?

BIOPSY KIT received FDA 510(k) clearance on 1989-07-17, under 510(k) number K892389.

Who is the listed applicant for BIOPSY KIT?

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

What is the FDA product code for BIOPSY KIT?

The FDA product code for BIOPSY KIT is LRO.

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Other records listing I M, 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.

K914600NEUROLOGICAL SPONGEK881363SYRINGE PREFILLED WITH WATERK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220K863785MAKLER CATHETER

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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

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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