FDA 510(k)

VAGINAL SPECULUM - DISPOSABLE

K-Number: K841909 · 1984-07-31

Decision Date1984-07-31

Product CodeHIB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

VAGINAL SPECULUM - DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Galenica Enterprises, Inc.. It received FDA 510(k) clearance on 1984-07-31 under 510(k) number K841909. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL SPECULUM - DISPOSABLE?

VAGINAL SPECULUM - DISPOSABLE is a medical device that received FDA 510(k) clearance on 1984-07-31. The listed applicant is Galenica Enterprises, Inc.. The 510(k) number is K841909.

When did VAGINAL SPECULUM - DISPOSABLE receive FDA 510(k) clearance?

VAGINAL SPECULUM - DISPOSABLE received FDA 510(k) clearance on 1984-07-31, under 510(k) number K841909.

Who is the listed applicant for VAGINAL SPECULUM - DISPOSABLE?

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

What is the FDA product code for VAGINAL SPECULUM - DISPOSABLE?

The FDA product code for VAGINAL SPECULUM - DISPOSABLE is HIB.

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Other records listing Galenica Enterprises, Inc. as applicant

K923656LIGHTING SOURCE SYSTEM K896383DISPOSABLE EXTERNAL CLAMPS K883283DISPOSABLE AMNIOTOME K861017GALENICA'S DISPOSABLE ANOSCOPES

Related Devices (Code: HIB)

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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.