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FDA 510(k)

MEGA DRESSING CHANGE KIT

K-Number: K910363 · 1991-03-28

ApplicantMegadyne Medical Products, Inc.
Decision Date1991-03-28
Product CodeMCY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEGA DRESSING CHANGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 1991-03-28 under 510(k) number K910363. 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 MEGA DRESSING CHANGE KIT?

MEGA DRESSING CHANGE KIT is a medical device that received FDA 510(k) clearance on 1991-03-28. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K910363.

When did MEGA DRESSING CHANGE KIT receive FDA 510(k) clearance?

MEGA DRESSING CHANGE KIT received FDA 510(k) clearance on 1991-03-28, under 510(k) number K910363.

Who is the listed applicant for MEGA DRESSING CHANGE KIT?

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

What is the FDA product code for MEGA DRESSING CHANGE KIT?

The FDA product code for MEGA DRESSING CHANGE KIT is MCY.

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Other records listing Megadyne Medical Products, 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.

K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)K213696ETHICON Megadyne Electrosurgical GeneratorK200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorK193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchK191328Megadyne Foot SwitchK080741MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE

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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.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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