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FDA 510(k)

SILICONE SOFT RELINE

K-Number: K981691 · 1998-11-03

ApplicantHarry J. Bosworth Co.
Decision Date1998-11-03
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILICONE SOFT RELINE is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K981691. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE SOFT RELINE?

SILICONE SOFT RELINE is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K981691.

When did SILICONE SOFT RELINE receive FDA 510(k) clearance?

SILICONE SOFT RELINE received FDA 510(k) clearance on 1998-11-03, under 510(k) number K981691.

Who is the listed applicant for SILICONE SOFT RELINE?

The FDA 510(k) record lists Harry J. Bosworth Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILICONE SOFT RELINE?

The FDA product code for SILICONE SOFT RELINE is EBI.

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Other records listing Harry J. Bosworth Co. 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: EBI)

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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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