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FDA 510(k)

KONTOUR ULTRA SOFT SPONGE #SS144.50

K-Number: K872069 · 1987-07-14

ApplicantWinfield Laboratories, Inc.
Decision Date1987-07-14
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

KONTOUR ULTRA SOFT SPONGE #SS144.50 is the device name listed in this FDA 510(k) record. The listed applicant is Winfield Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-14 under 510(k) number K872069. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KONTOUR ULTRA SOFT SPONGE #SS144.50?

KONTOUR ULTRA SOFT SPONGE #SS144.50 is a medical device that received FDA 510(k) clearance on 1987-07-14. The listed applicant is Winfield Laboratories, Inc.. The 510(k) number is K872069.

When did KONTOUR ULTRA SOFT SPONGE #SS144.50 receive FDA 510(k) clearance?

KONTOUR ULTRA SOFT SPONGE #SS144.50 received FDA 510(k) clearance on 1987-07-14, under 510(k) number K872069.

Who is the listed applicant for KONTOUR ULTRA SOFT SPONGE #SS144.50?

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

What is the FDA product code for KONTOUR ULTRA SOFT SPONGE #SS144.50?

The FDA product code for KONTOUR ULTRA SOFT SPONGE #SS144.50 is NAD.

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Other records listing Winfield Laboratories, 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.

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Related Devices (Code: NAD)

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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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