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FDA 510(k)

BIOPSY TRAY

K-Number: K970152 · 1997-03-05

ApplicantMedcare Medical Group, Inc.
Decision Date1997-03-05
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOPSY TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Medical Group, Inc.. It received FDA 510(k) clearance on 1997-03-05 under 510(k) number K970152. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOPSY TRAY?

BIOPSY TRAY is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is Medcare Medical Group, Inc.. The 510(k) number is K970152.

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

BIOPSY TRAY received FDA 510(k) clearance on 1997-03-05, under 510(k) number K970152.

Who is the listed applicant for BIOPSY TRAY?

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

What is the FDA product code for BIOPSY TRAY?

The FDA product code for BIOPSY TRAY is FRG.

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Other records listing Medcare Medical Group, 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.

K973497HUBERLOCK962849CATHETER INSERTION TRAYK961075MEDCARE REGIONAL ANETHESIA KITK962328SINGLE USE INSTRUMENT TRAYK962527GENERAL PURPOSE DENTAL TRAYK961880MEDCARE SUCTION CONNECTING TUBING

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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