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FDA 510(k)

VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY

K-Number: K891038 · 1989-03-17

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-03-17
Product CodeHDL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY 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 1989-03-17 under 510(k) number K891038. The device is classified under product code HDL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY?

VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891038.

When did VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY receive FDA 510(k) clearance?

VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY received FDA 510(k) clearance on 1989-03-17, under 510(k) number K891038.

Who is the listed applicant for VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY?

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 VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY?

The FDA product code for VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY is HDL.

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Related Devices (Code: HDL)

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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.

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