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FDA 510(k)

BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF

K-Number: K912284 · 1991-08-19

ApplicantDouglas James Donaldson Compliance Services
Decision Date1991-08-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Douglas James Donaldson Compliance Services. It received FDA 510(k) clearance on 1991-08-19 under 510(k) number K912284. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF?

BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF is a medical device that received FDA 510(k) clearance on 1991-08-19. The listed applicant is Douglas James Donaldson Compliance Services. The 510(k) number is K912284.

When did BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF receive FDA 510(k) clearance?

BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF received FDA 510(k) clearance on 1991-08-19, under 510(k) number K912284.

Who is the listed applicant for BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF?

The FDA 510(k) record lists Douglas James Donaldson Compliance Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF?

The FDA product code for BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF is GEX. This falls under the Gastroenterology category.

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Other records listing Douglas James Donaldson Compliance Services as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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