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FDA 510(k)

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU

K-Number: K892542 · 1989-05-09

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-05-09
Product CodeFFN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU 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 1989-05-09 under 510(k) number K892542. The device is classified under product code FFN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU?

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K892542.

When did RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU receive FDA 510(k) clearance?

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU received FDA 510(k) clearance on 1989-05-09, under 510(k) number K892542.

Who is the listed applicant for RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU?

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 RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU?

The FDA product code for RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU is FFN.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Related Devices (Code: FFN)

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.

K932408AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETSBaxter Healthcare CorpK892550BEST COLON CLAMPZinnanti Surgical Instruments, Inc.K772405TUBING CLAMPFred Sammons, Inc.K771421CATHETEO CLAMPQuinton, 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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