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FDA 510(k)

INSUFFLATOR TUBING KIT W/FILTER

K-Number: K933661 · 1993-08-25

ApplicantEagle Medical, Inc.
Decision Date1993-08-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSUFFLATOR TUBING KIT W/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Medical, Inc.. It received FDA 510(k) clearance on 1993-08-25 under 510(k) number K933661. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFFLATOR TUBING KIT W/FILTER?

INSUFFLATOR TUBING KIT W/FILTER is a medical device that received FDA 510(k) clearance on 1993-08-25. The listed applicant is Eagle Medical, Inc.. The 510(k) number is K933661.

When did INSUFFLATOR TUBING KIT W/FILTER receive FDA 510(k) clearance?

INSUFFLATOR TUBING KIT W/FILTER received FDA 510(k) clearance on 1993-08-25, under 510(k) number K933661.

Who is the listed applicant for INSUFFLATOR TUBING KIT W/FILTER?

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

What is the FDA product code for INSUFFLATOR TUBING KIT W/FILTER?

The FDA product code for INSUFFLATOR TUBING KIT W/FILTER is GCJ.

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Other records listing Eagle Medical, 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.

K915591STERILE GAUZE PADSK891795DISPOSABLE LATEX EXAM GLOVES

Related Devices (Code: GCJ)

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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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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