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FDA 510(k)

REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION

K-Number: K952396 · 1995-08-15

ApplicantContour Fabricators of Florida, Inc.
Decision Date1995-08-15
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Contour Fabricators of Florida, Inc.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K952396. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION?

REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Contour Fabricators of Florida, Inc.. The 510(k) number is K952396.

When did REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION receive FDA 510(k) clearance?

REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION received FDA 510(k) clearance on 1995-08-15, under 510(k) number K952396.

Who is the listed applicant for REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION?

The FDA 510(k) record lists Contour Fabricators of Florida, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION?

The FDA product code for REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION is BSY.

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Other records listing Contour Fabricators of Florida, 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.

K955685RNS STERILE, DISPOSABLE CT BIOPSY TRAYK962040RNS ARTHROGRAM TRAYK955687RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAYK955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYK955684RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAYK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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