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FDA 510(k)

GLOVE-N-GEL AMNIOTOMY KIT

K-Number: K910518 · 1991-05-09

ApplicantEpcom Medical Systems, Inc.
Decision Date1991-05-09
Product CodeHGE
Advisory CommitteeOB
DecisionUnknown

Device Summary

GLOVE-N-GEL AMNIOTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Epcom Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K910518. The device is classified under product code HGE. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GLOVE-N-GEL AMNIOTOMY KIT?

GLOVE-N-GEL AMNIOTOMY KIT is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K910518.

When did GLOVE-N-GEL AMNIOTOMY KIT receive FDA 510(k) clearance?

GLOVE-N-GEL AMNIOTOMY KIT received FDA 510(k) clearance on 1991-05-09, under 510(k) number K910518.

Who is the listed applicant for GLOVE-N-GEL AMNIOTOMY KIT?

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

What is the FDA product code for GLOVE-N-GEL AMNIOTOMY KIT?

The FDA product code for GLOVE-N-GEL AMNIOTOMY KIT is HGE.

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Other records listing Epcom Medical Systems, Inc. as applicant

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Related Devices (Code: HGE)

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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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