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FDA 510(k)

DIAGNOSTIC DILATATION & MENSTRUAL KIT

K-Number: K840384 · 1984-04-30

ApplicantIntl. Medical Technologies, Inc.
Decision Date1984-04-30
Product CodeHHI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC DILATATION & MENSTRUAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Technologies, Inc.. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K840384. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC DILATATION & MENSTRUAL KIT?

DIAGNOSTIC DILATATION & MENSTRUAL KIT is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Intl. Medical Technologies, Inc.. The 510(k) number is K840384.

When did DIAGNOSTIC DILATATION & MENSTRUAL KIT receive FDA 510(k) clearance?

DIAGNOSTIC DILATATION & MENSTRUAL KIT received FDA 510(k) clearance on 1984-04-30, under 510(k) number K840384.

Who is the listed applicant for DIAGNOSTIC DILATATION & MENSTRUAL KIT?

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

What is the FDA product code for DIAGNOSTIC DILATATION & MENSTRUAL KIT?

The FDA product code for DIAGNOSTIC DILATATION & MENSTRUAL KIT is HHI.

Related Clinical Trials

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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Other records listing Intl. Medical Technologies, 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.

K840383MENSTRUAL ASPIRATION KITK840381TAPERED CERVICAL DILATORK840380UTERINE SOUNDK840382VACUUM ASPIRATION CATHETER

Related Devices (Code: HHI)

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.

K171440Berkeley VC-10 Vacuum Curettage SystemGyrus AcmiK030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMAcmi CorporationK983181CYTOPREPCytoprep Inc. Est.K931205MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTERBaxter Healthcare CorpK904160CYTOSMEAR BRUSHBrooke Intl.K900641CANNULA, SUCTION UTERINEWilliams Specialty Products, 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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