FDA 510(k)

DISPOSABLE PLASTIC VAGINAL SPECULA

K-Number: K894957 · 1989-10-12

ApplicantZinnanti Surgical Instruments, Inc.

Decision Date1989-10-12

Product CodeHIB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PLASTIC VAGINAL SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894957. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE PLASTIC VAGINAL SPECULA?

DISPOSABLE PLASTIC VAGINAL SPECULA is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K894957.

When did DISPOSABLE PLASTIC VAGINAL SPECULA receive FDA 510(k) clearance?

DISPOSABLE PLASTIC VAGINAL SPECULA received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894957.

Who is the listed applicant for DISPOSABLE PLASTIC VAGINAL SPECULA?

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

What is the FDA product code for DISPOSABLE PLASTIC VAGINAL SPECULA?

The FDA product code for DISPOSABLE PLASTIC VAGINAL SPECULA is HIB.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Related Devices (Code: HIB)

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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.