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FDA 510(k)

DISPOSABLE AMNIOTOME

K-Number: K883283 · 1988-10-18

ApplicantGalenica Enterprises, Inc.
Decision Date1988-10-18
Product CodeHGG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE AMNIOTOME 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 1988-10-18 under 510(k) number K883283. The device is classified under product code HGG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE AMNIOTOME?

DISPOSABLE AMNIOTOME is a medical device that received FDA 510(k) clearance on 1988-10-18. The listed applicant is Galenica Enterprises, Inc.. The 510(k) number is K883283.

When did DISPOSABLE AMNIOTOME receive FDA 510(k) clearance?

DISPOSABLE AMNIOTOME received FDA 510(k) clearance on 1988-10-18, under 510(k) number K883283.

Who is the listed applicant for DISPOSABLE AMNIOTOME?

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 DISPOSABLE AMNIOTOME?

The FDA product code for DISPOSABLE AMNIOTOME is HGG.

Related Clinical Trials

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Other records listing Galenica Enterprises, Inc. 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.

K923656LIGHTING SOURCE SYSTEMK896383DISPOSABLE EXTERNAL CLAMPSK861017GALENICA'S DISPOSABLE ANOSCOPESK841909VAGINAL SPECULUM - DISPOSABLE

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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