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FDA 510(k)

STERILE ISOTONIC SALINE & STERILE WATER

K-Number: K954442 · 1995-12-21

ApplicantMedcare Custom Packaging, Inc.
Decision Date1995-12-21
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE ISOTONIC SALINE & STERILE WATER is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K954442. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE ISOTONIC SALINE & STERILE WATER?

STERILE ISOTONIC SALINE & STERILE WATER is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K954442.

When did STERILE ISOTONIC SALINE & STERILE WATER receive FDA 510(k) clearance?

STERILE ISOTONIC SALINE & STERILE WATER received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954442.

Who is the listed applicant for STERILE ISOTONIC SALINE & STERILE WATER?

The FDA 510(k) record lists Medcare Custom Packaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE ISOTONIC SALINE & STERILE WATER?

The FDA product code for STERILE ISOTONIC SALINE & STERILE WATER is JOL.

Related Clinical Trials

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Other records listing Medcare Custom Packaging, 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.

K954869MEDCARE YANKAUER SUCTION DEVICEK952759TOWEL PACKK950390URETHRAL CATHETERIZATION TRAYK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK951149SINGLE USE INSTRUMENT TRAYK934732PELVIC EXAM TRAY

View all 11 devices →

Related Devices (Code: JOL)

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.

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare CorpK000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories

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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