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FDA 510(k)

LAMINARIA JAPONICA CERVICAL DILATOR

K-Number: K833068 · 1984-02-04

ApplicantMedi-Spec
Decision Date1984-02-04
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAMINARIA JAPONICA CERVICAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Spec. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K833068. 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 JAPONICA CERVICAL DILATOR?

LAMINARIA JAPONICA CERVICAL DILATOR is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Medi-Spec. The 510(k) number is K833068.

When did LAMINARIA JAPONICA CERVICAL DILATOR receive FDA 510(k) clearance?

LAMINARIA JAPONICA CERVICAL DILATOR received FDA 510(k) clearance on 1984-02-04, under 510(k) number K833068.

Who is the listed applicant for LAMINARIA JAPONICA CERVICAL DILATOR?

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

What is the FDA product code for LAMINARIA JAPONICA CERVICAL DILATOR?

The FDA product code for LAMINARIA JAPONICA CERVICAL DILATOR is HDY.

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Other records listing Medi-Spec 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.

K812694WHISK-RK812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)K801554STERILE CAST PADDINGK800404MEDSPEC OPERATIVE OPTHALMIC KITK800490STERILE DRESSING PACKK790952CLAMP COVERS

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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.K892220LAMINARIA TENTBerkeley MedevicesK881295LAMINARIA CUREXHarold W. Berger Co.

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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