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FDA 510(k)

SILICONE INSTRUMENT SHODS

K-Number: K895591 · 1989-10-20

ApplicantKey Surgical, Inc.
Decision Date1989-10-20
Product CodeGDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE INSTRUMENT SHODS is the device name listed in this FDA 510(k) record. The listed applicant is Key Surgical, Inc.. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K895591. The device is classified under product code GDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE INSTRUMENT SHODS?

SILICONE INSTRUMENT SHODS is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Key Surgical, Inc.. The 510(k) number is K895591.

When did SILICONE INSTRUMENT SHODS receive FDA 510(k) clearance?

SILICONE INSTRUMENT SHODS received FDA 510(k) clearance on 1989-10-20, under 510(k) number K895591.

Who is the listed applicant for SILICONE INSTRUMENT SHODS?

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

What is the FDA product code for SILICONE INSTRUMENT SHODS?

The FDA product code for SILICONE INSTRUMENT SHODS is GDJ.

Related Clinical Trials

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Other records listing Key Surgical, 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.

K910328KEY COMFORT GRIPSK896676KEY VASCULAR LOOPSK896472KEY VASCULAR BOOTIES

Related Devices (Code: GDJ)

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.

K153358Standard ClampStandard BariatricsK930315THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCEThomasville Medical Assoc.K924223MAR-MED LIVER STRAPMar-Med Co.K922659GENERAL SURGERY CLAMP AND NEEDLE HOLDERMiltex Instrument Co.K914913GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYSTIdeal Medical, Inc.K900956GS-7100 CHOLANGIOGRAM CLAMP, 5MMSolos Endoscopy, Inc.

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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