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FDA 510(k)

X-RAY DETECTABLE COTTON BALLS

K-Number: K854714 · 1985-12-17

ApplicantAmerican Silk Sutures, Inc.
Decision Date1985-12-17
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

X-RAY DETECTABLE COTTON BALLS is the device name listed in this FDA 510(k) record. The listed applicant is American Silk Sutures, Inc.. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K854714. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY DETECTABLE COTTON BALLS?

X-RAY DETECTABLE COTTON BALLS is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is American Silk Sutures, Inc.. The 510(k) number is K854714.

When did X-RAY DETECTABLE COTTON BALLS receive FDA 510(k) clearance?

X-RAY DETECTABLE COTTON BALLS received FDA 510(k) clearance on 1985-12-17, under 510(k) number K854714.

Who is the listed applicant for X-RAY DETECTABLE COTTON BALLS?

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

What is the FDA product code for X-RAY DETECTABLE COTTON BALLS?

The FDA product code for X-RAY DETECTABLE COTTON BALLS is GDY.

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Related Devices (Code: GDY)

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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