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FDA 510(k)

CATHETER IRRIGATION TRAYS, #3300, 3310 &

K-Number: K801783 · 1980-08-13

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1980-08-13
Product CodeEYN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER IRRIGATION TRAYS, #3300, 3310 & is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801783. 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 CATHETER IRRIGATION TRAYS, #3300, 3310 &?

CATHETER IRRIGATION TRAYS, #3300, 3310 & is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K801783.

When did CATHETER IRRIGATION TRAYS, #3300, 3310 & receive FDA 510(k) clearance?

CATHETER IRRIGATION TRAYS, #3300, 3310 & received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801783.

Who is the listed applicant for CATHETER IRRIGATION TRAYS, #3300, 3310 &?

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

What is the FDA product code for CATHETER IRRIGATION TRAYS, #3300, 3310 &?

The FDA product code for CATHETER IRRIGATION TRAYS, #3300, 3310 & is EYN.

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Other records listing The Healthcare Group Laboratories, 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

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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.K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican 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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