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FDA 510(k)

TPN TRAY (STERILE)

K-Number: K925021 · 1993-06-07

ApplicantCustomed, Inc.
Decision Date1993-06-07
Product CodeMCY
Advisory CommitteeHO
DecisionUnknown

Device Summary

TPN TRAY (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1993-06-07 under 510(k) number K925021. The device is classified under product code MCY. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TPN TRAY (STERILE)?

TPN TRAY (STERILE) is a medical device that received FDA 510(k) clearance on 1993-06-07. The listed applicant is Customed, Inc.. The 510(k) number is K925021.

When did TPN TRAY (STERILE) receive FDA 510(k) clearance?

TPN TRAY (STERILE) received FDA 510(k) clearance on 1993-06-07, under 510(k) number K925021.

Who is the listed applicant for TPN TRAY (STERILE)?

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

What is the FDA product code for TPN TRAY (STERILE)?

The FDA product code for TPN TRAY (STERILE) is MCY.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

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Related Devices (Code: MCY)

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.

K970721DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEMJohnson & Johnson Medical, Inc.K963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAYGrand Medical ProductsK960585WOUND CARE COMPRESSION SYSTEM (WCCS)Suncoast Medical Products, Inc.K952334DRESSING CHANGE TRAYBusse Hospital Disposables, Inc.K951021CIRCULON SYSTEM STEP 2Convatec, A Division of E.R. Squibb & SonsK951022CIRCULON SYSTEM STEP 1Convatec, A Division of E.R. Squibb & Sons

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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