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FDA 510(k)

IRRIGATION TRAY

K-Number: K781748 · 1978-12-12

ApplicantIntermed, Inc.
Decision Date1978-12-12
Product CodeEYN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1978-12-12 under 510(k) number K781748. The device is classified under product code EYN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION TRAY?

IRRIGATION TRAY is a medical device that received FDA 510(k) clearance on 1978-12-12. The listed applicant is Intermed, Inc.. The 510(k) number is K781748.

When did IRRIGATION TRAY receive FDA 510(k) clearance?

IRRIGATION TRAY received FDA 510(k) clearance on 1978-12-12, under 510(k) number K781748.

Who is the listed applicant for IRRIGATION TRAY?

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

What is the FDA product code for IRRIGATION TRAY?

The FDA product code for IRRIGATION TRAY is EYN.

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Other records listing Intermed, 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.

K900857NON STERILE PARENTERAL SUPPLY KITK842166INTERMED, INS STERILE WATER/SALINEK833126DRESSING CHANGE TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833574PERCUTANEOUS SHEATH INTRODUCER TRAYSK833139ACUTE HEMODIALYSIS TRAYS

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Related Devices (Code: EYN)

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.

K944882IRRIGATION TRAYClinical Resources, Inc.K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.K900148KIT PAK IRRIGATION TRAYKit Pak, 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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