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FDA 510(k)

KENDALL CURITY PETROLATUM GAUZE

K-Number: K973511 · 1997-12-16

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1997-12-16
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

KENDALL CURITY PETROLATUM GAUZE 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 1997-12-16 under 510(k) number K973511. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KENDALL CURITY PETROLATUM GAUZE?

KENDALL CURITY PETROLATUM GAUZE is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K973511.

When did KENDALL CURITY PETROLATUM GAUZE receive FDA 510(k) clearance?

KENDALL CURITY PETROLATUM GAUZE received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973511.

Who is the listed applicant for KENDALL CURITY PETROLATUM GAUZE?

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 KENDALL CURITY PETROLATUM GAUZE?

The FDA product code for KENDALL CURITY PETROLATUM GAUZE is FRO. This falls under the Anesthesiology category.

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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 STRIPK973507KENDALL 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 CATHETERK970266KENDALL HYDROPHILIC POWDER WOUND DRESSING

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Related Devices (Code: FRO)

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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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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