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FDA 510(k)

ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT

K-Number: K121604 · 2012-07-27

ApplicantObp Corporation
Decision Date2012-07-27
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Obp Corporation. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K121604. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT?

ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Obp Corporation. The 510(k) number is K121604.

When did ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT receive FDA 510(k) clearance?

ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT received FDA 510(k) clearance on 2012-07-27, under 510(k) number K121604.

Who is the listed applicant for ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT?

The FDA 510(k) record lists Obp Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT?

The FDA product code for ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT is FER.

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Other records listing Obp Corporation 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.

K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM

Related Devices (Code: FER)

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

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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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