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FDA 510(k)

SHEER THIN

K-Number: K984488 · 1999-02-01

ApplicantTwe Companies, Inc.
Decision Date1999-02-01
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHEER THIN is the device name listed in this FDA 510(k) record. The listed applicant is Twe Companies, Inc.. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K984488. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEER THIN?

SHEER THIN is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Twe Companies, Inc.. The 510(k) number is K984488.

When did SHEER THIN receive FDA 510(k) clearance?

SHEER THIN received FDA 510(k) clearance on 1999-02-01, under 510(k) number K984488.

Who is the listed applicant for SHEER THIN?

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

What is the FDA product code for SHEER THIN?

The FDA product code for SHEER THIN is HIS.

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Related Devices (Code: HIS)

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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