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FDA 510(k)

DRESSING CHANGE TRAY

K-Number: K952334 · 1995-07-14

ApplicantBusse Hospital Disposables, Inc.
Decision Date1995-07-14
Product CodeMCY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRESSING CHANGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K952334. 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 DRESSING CHANGE TRAY?

DRESSING CHANGE TRAY is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K952334.

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

DRESSING CHANGE TRAY received FDA 510(k) clearance on 1995-07-14, under 510(k) number K952334.

Who is the listed applicant for DRESSING CHANGE TRAY?

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

What is the FDA product code for DRESSING CHANGE TRAY?

The FDA product code for DRESSING CHANGE TRAY is MCY.

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Other records listing Busse Hospital Disposables, 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.

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEK093909BUSSE SURGICAL DRAPES IVK092212BUSSE SURGICAL DRAPES IIIK082297BUSSE SURGICAL DRAPEK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETER

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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.K951021CIRCULON SYSTEM STEP 2Convatec, A Division of E.R. Squibb & SonsK951022CIRCULON SYSTEM STEP 1Convatec, A Division of E.R. Squibb & SonsK951476E-PACK PROCEDURE KITSETHICON, 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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