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FDA 510(k)

LIGHTING SOURCE SYSTEM

K-Number: K923656 · 1994-09-08

ApplicantGalenica Enterprises, Inc.
Decision Date1994-09-08
Product CodeHIC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIGHTING SOURCE SYSTEM 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 1994-09-08 under 510(k) number K923656. The device is classified under product code HIC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTING SOURCE SYSTEM?

LIGHTING SOURCE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-08. The listed applicant is Galenica Enterprises, Inc.. The 510(k) number is K923656.

When did LIGHTING SOURCE SYSTEM receive FDA 510(k) clearance?

LIGHTING SOURCE SYSTEM received FDA 510(k) clearance on 1994-09-08, under 510(k) number K923656.

Who is the listed applicant for LIGHTING SOURCE SYSTEM?

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 LIGHTING SOURCE SYSTEM?

The FDA product code for LIGHTING SOURCE SYSTEM is HIC.

Related Clinical Trials

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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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.

K896383DISPOSABLE EXTERNAL CLAMPSK883283DISPOSABLE AMNIOTOMEK861017GALENICA'S DISPOSABLE ANOSCOPESK841909VAGINAL SPECULUM - DISPOSABLE

Related Devices (Code: HIC)

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.

K955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYTrylon Corp.K902516NEW LENGTH SUGITA APPLIERSSims Surgical, Inc.K897100CENTURION VAGINAL SPECULUMTri-State Hospital Supply Corp.K853257SPECULITE DISPOSABLE VAGINAL LIGHTTrylon Associates, Ltd.

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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