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FDA 510(k)

BIOPSY TRAY I & II

K-Number: K854095 · 1985-11-25

ApplicantNorth Coast Medi-Tek
Decision Date1985-11-25
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

BIOPSY TRAY I & II is the device name listed in this FDA 510(k) record. The listed applicant is North Coast Medi-Tek. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854095. 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 TRAY I & II?

BIOPSY TRAY I & II is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is North Coast Medi-Tek. The 510(k) number is K854095.

When did BIOPSY TRAY I & II receive FDA 510(k) clearance?

BIOPSY TRAY I & II received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854095.

Who is the listed applicant for BIOPSY TRAY I & II?

The FDA 510(k) record lists North Coast Medi-Tek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY TRAY I & II?

The FDA product code for BIOPSY TRAY I & II is LRO.

Related Clinical Trials

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Other records listing North Coast Medi-Tek 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.

K870419IVR-SP CUSTOM ANGIOGRAPHY TRAYK870420PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHYK870416LP EXTENSION SETSK870418MYA-1 AND MYT-1 MYELOGRAM TRAYK870417RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY

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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