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FDA 510(k)

JAIN GRAFT ASSIST

K-Number: K904536 · 1990-11-29

ApplicantJain Surgical Equipment, Inc.
Decision Date1990-11-29
Product CodeGCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JAIN GRAFT ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Jain Surgical Equipment, Inc.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904536. The device is classified under product code GCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAIN GRAFT ASSIST?

JAIN GRAFT ASSIST is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Jain Surgical Equipment, Inc.. The 510(k) number is K904536.

When did JAIN GRAFT ASSIST receive FDA 510(k) clearance?

JAIN GRAFT ASSIST received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904536.

Who is the listed applicant for JAIN GRAFT ASSIST?

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

What is the FDA product code for JAIN GRAFT ASSIST?

The FDA product code for JAIN GRAFT ASSIST is GCZ.

Related Clinical Trials

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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Other records listing Jain Surgical Equipment, 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.

K913896JAIN BLOOD SHIELDK911077JAIN SUTURE PACKAGE COUNTERK911076JAIN QUICK COUNTK905105JAIN SUTURE/VESIBAND ORGANIZER

Related Devices (Code: GCZ)

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.

K893870ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.K802806VISECERA RETAINERAdept-Med Intl., Inc.K801610CHILDREN'S HOSPITAL PEDIATRIC RETRACTOREdward Weck, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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