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FDA 510(k)

G-TUBE DRESSING CHANGE TRAY

K-Number: K905123 · 1991-03-27

ApplicantContinental Medical Laboratories, Inc.
Decision Date1991-03-27
Product CodeMCY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

G-TUBE DRESSING CHANGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Continental Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K905123. The device is classified under product code MCY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-TUBE DRESSING CHANGE TRAY?

G-TUBE DRESSING CHANGE TRAY is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Continental Medical Laboratories, Inc.. The 510(k) number is K905123.

When did G-TUBE DRESSING CHANGE TRAY receive FDA 510(k) clearance?

G-TUBE DRESSING CHANGE TRAY received FDA 510(k) clearance on 1991-03-27, under 510(k) number K905123.

Who is the listed applicant for G-TUBE DRESSING CHANGE TRAY?

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

What is the FDA product code for G-TUBE DRESSING CHANGE TRAY?

The FDA product code for G-TUBE DRESSING CHANGE TRAY is MCY.

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Other records listing Continental Medical Laboratories, 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.

K964827PROD. NO. 01-132 - SUTURE REMOVAL KITK963234STAPLE REMOVAL KITK963443PROD. NO. 02-031 - LACERATION TRAYK962078TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETERK954728PROD NO. 01-1694 - 4X4 FOAM DRESSINGK962073URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY

View all 8 devices →

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.K951022CIRCULON SYSTEM STEP 1Convatec, A Division of E.R. Squibb & SonsK951021CIRCULON SYSTEM STEP 2Convatec, 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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