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FDA 510(k)

LAMINARIA TENT

K-Number: K892220 · 1989-06-14

ApplicantBerkeley Medevices
Decision Date1989-06-14
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAMINARIA TENT is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Medevices. It received FDA 510(k) clearance on 1989-06-14 under 510(k) number K892220. The device is classified under product code HDY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMINARIA TENT?

LAMINARIA TENT is a medical device that received FDA 510(k) clearance on 1989-06-14. The listed applicant is Berkeley Medevices. The 510(k) number is K892220.

When did LAMINARIA TENT receive FDA 510(k) clearance?

LAMINARIA TENT received FDA 510(k) clearance on 1989-06-14, under 510(k) number K892220.

Who is the listed applicant for LAMINARIA TENT?

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

What is the FDA product code for LAMINARIA TENT?

The FDA product code for LAMINARIA TENT is HDY.

Related Clinical Trials

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Other records listing Berkeley Medevices 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.

K840952MEDEVICE V-80 VACUUM PUMPK823006MEDEVICES ASPIRATION HOSEK812388SURGICAL PAWSK812389SURGICAL LOOPS

Related Devices (Code: HDY)

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.

K040625ATAD ARD CATHETERAtad Developments , Ltd.K021012LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLCK011512MMODIFICATION TO LAMINARIAA & A Medical, Inc.K955072LAMINARIACti Corp., Ltd.K881295LAMINARIA CUREXHarold W. Berger Co.K881312LAMINARIABusse Hospital Disposables, 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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