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FDA 510(k)

CERVICAL DILATOR

K-Number: K811568 · 1981-07-16

ApplicantGynemetrics, Inc.
Decision Date1981-07-16
Product CodeHDQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVICAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gynemetrics, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811568. The device is classified under product code HDQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVICAL DILATOR?

CERVICAL DILATOR is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Gynemetrics, Inc.. The 510(k) number is K811568.

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

CERVICAL DILATOR received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811568.

Who is the listed applicant for CERVICAL DILATOR?

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

What is the FDA product code for CERVICAL DILATOR?

The FDA product code for CERVICAL DILATOR is HDQ.

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 Gynemetrics, 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.

K803210MENSTRUAL ASPIRATION KITSK802313UTERINE CURETTEK802315UTERINE SOUND

Related Devices (Code: HDQ)

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.

K930034CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTONThomasville Medical Assoc.K896701TEFLON CERVICAL ACCESS SETCook Ob/GynK891029CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALLZinnanti Surgical Instruments, Inc.K890377FIXED-SIZE UTERINE DILATORKinetic Medical ProductsK791277MODEL 6500 EXTRACTION IRRIGATION SYSCavitron Corp.

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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