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FDA 510(k)

RETRACTOR RODS

K-Number: K891398 · 1989-05-11

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-05-11
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RETRACTOR RODS 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 1989-05-11 under 510(k) number K891398. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETRACTOR RODS?

RETRACTOR RODS is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891398.

When did RETRACTOR RODS receive FDA 510(k) clearance?

RETRACTOR RODS received FDA 510(k) clearance on 1989-05-11, under 510(k) number K891398.

Who is the listed applicant for RETRACTOR RODS?

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 RETRACTOR RODS?

The FDA product code for RETRACTOR RODS is KNA.

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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: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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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