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FDA 510(k)

WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE

K-Number: K891037 · 1989-03-17

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

Device Summary

WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE 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 K891037. The device is classified under product code HFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE?

WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE 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 K891037.

When did WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE receive FDA 510(k) clearance?

WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE received FDA 510(k) clearance on 1989-03-17, under 510(k) number K891037.

Who is the listed applicant for WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE?

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 WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE?

The FDA product code for WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE is HFD.

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Other records listing Zinnanti Surgical Instruments, 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.

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Related Devices (Code: HFD)

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.

K890376VAGINAL SPECULUMKinetic Medical ProductsK810558SKIN SCRUB TRAYAssociated Medical Products 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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