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FDA 510(k)

WOUND CARE TRAY B

K-Number: K913479 · 1991-10-08

ApplicantCatalina Biomedical Corp.
Decision Date1991-10-08
Product CodeMCY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WOUND CARE TRAY B is the device name listed in this FDA 510(k) record. The listed applicant is Catalina Biomedical Corp.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913479. 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 WOUND CARE TRAY B?

WOUND CARE TRAY B is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Catalina Biomedical Corp.. The 510(k) number is K913479.

When did WOUND CARE TRAY B receive FDA 510(k) clearance?

WOUND CARE TRAY B received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913479.

Who is the listed applicant for WOUND CARE TRAY B?

The FDA 510(k) record lists Catalina Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOUND CARE TRAY B?

The FDA product code for WOUND CARE TRAY B is MCY.

Related Clinical Trials

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.

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Other records listing Catalina Biomedical Corp. 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.

K920050BIOLEX WOUND GEL,K913480WOUND CARE TRAY AK896358VARI/MOIST WOUND DRESSINGK896421TRANSPARENT FILM I.V. SITE/WOUND DRESSING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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