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FDA 510(k)

TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE

K-Number: K940574 · 1994-04-20

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1994-04-20
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1994-04-20 under 510(k) number K940574. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE?

TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE is a medical device that received FDA 510(k) clearance on 1994-04-20. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K940574.

When did TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE receive FDA 510(k) clearance?

TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE received FDA 510(k) clearance on 1994-04-20, under 510(k) number K940574.

Who is the listed applicant for TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE?

The FDA product code for TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE is EFQ.

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Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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