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FDA 510(k)

DISPOSABLE EXTERNAL CLAMPS

K-Number: K896383 · 1989-12-06

ApplicantGalenica Enterprises, Inc.
Decision Date1989-12-06
Product CodeGDI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE EXTERNAL CLAMPS 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 1989-12-06 under 510(k) number K896383. The device is classified under product code GDI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE EXTERNAL CLAMPS?

DISPOSABLE EXTERNAL CLAMPS is a medical device that received FDA 510(k) clearance on 1989-12-06. The listed applicant is Galenica Enterprises, Inc.. The 510(k) number is K896383.

When did DISPOSABLE EXTERNAL CLAMPS receive FDA 510(k) clearance?

DISPOSABLE EXTERNAL CLAMPS received FDA 510(k) clearance on 1989-12-06, under 510(k) number K896383.

Who is the listed applicant for DISPOSABLE EXTERNAL CLAMPS?

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 EXTERNAL CLAMPS?

The FDA product code for DISPOSABLE EXTERNAL CLAMPS is GDI.

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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 SYSTEMK883283DISPOSABLE AMNIOTOMEK861017GALENICA'S DISPOSABLE ANOSCOPESK841909VAGINAL SPECULUM - DISPOSABLE

Related Devices (Code: GDI)

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.

K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic InstrumentationK831912ROUND-BEEHIVE- DISSECTORS 3/8Ormed Mfg., Inc.K822569TYMPANOPLASTY & SKIN DISSECTORSKelleher Corp.K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.K791703TEW BYPASS INSTRUMENTS & DISSECTING KITEdward Weck, Inc.

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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