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FDA 510(k)

KOOL GARD SINGLES GOWN

K-Number: K952114 · 1995-09-25

ApplicantAmerican Threshold Industries, Inc.
Decision Date1995-09-25
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KOOL GARD SINGLES GOWN is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K952114. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOOL GARD SINGLES GOWN?

KOOL GARD SINGLES GOWN is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K952114.

When did KOOL GARD SINGLES GOWN receive FDA 510(k) clearance?

KOOL GARD SINGLES GOWN received FDA 510(k) clearance on 1995-09-25, under 510(k) number K952114.

Who is the listed applicant for KOOL GARD SINGLES GOWN?

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

What is the FDA product code for KOOL GARD SINGLES GOWN?

The FDA product code for KOOL GARD SINGLES GOWN is FYC.

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Other records listing American Threshold Industries, 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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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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