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FDA 510(k)

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE

K-Number: K993716 · 1999-12-21

ApplicantHarry J. Bosworth Co.
Decision Date1999-12-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE 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 1999-12-21 under 510(k) number K993716. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE?

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K993716.

When did PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE receive FDA 510(k) clearance?

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993716.

Who is the listed applicant for PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE?

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 PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE?

The FDA product code for PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE is EBF.

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Other records listing Harry J. Bosworth Co. as applicant

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Related Devices (Code: EBF)

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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