FDA 510(k)

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET

K-Number: K972731 · 1997-09-29

Decision Date1997-09-29

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Klein-Baker Medical, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K972731. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET?

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Klein-Baker Medical, Inc.. The 510(k) number is K972731.

When did NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET receive FDA 510(k) clearance?

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET received FDA 510(k) clearance on 1997-09-29, under 510(k) number K972731.

Who is the listed applicant for NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET?

The FDA 510(k) record lists Klein-Baker Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET?

The FDA product code for NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET is KDJ.

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Other records listing Klein-Baker Medical, Inc. as applicant

K970997NEO-CARE LUMBER PUNCTURE KIT K970434NEO-PICC K963972NEO-CARE DUAL LUMEN UMBILICAL CATHETER K963867NEO-CARE CATHETERIZATION TRAY

Related Devices (Code: KDJ)

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.