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FDA 510(k)

STERILE WATER SOLUTION CATALOG # 10000

K-Number: K904216 · 1990-11-16

ApplicantSuperior Healthcare Group, Inc.
Decision Date1990-11-16
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE WATER SOLUTION CATALOG # 10000 is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1990-11-16 under 510(k) number K904216. 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 WATER SOLUTION CATALOG # 10000?

STERILE WATER SOLUTION CATALOG # 10000 is a medical device that received FDA 510(k) clearance on 1990-11-16. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K904216.

When did STERILE WATER SOLUTION CATALOG # 10000 receive FDA 510(k) clearance?

STERILE WATER SOLUTION CATALOG # 10000 received FDA 510(k) clearance on 1990-11-16, under 510(k) number K904216.

Who is the listed applicant for STERILE WATER SOLUTION CATALOG # 10000?

The FDA 510(k) record lists Superior Healthcare Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE WATER SOLUTION CATALOG # 10000?

The FDA product code for STERILE WATER SOLUTION CATALOG # 10000 is JOL.

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Other records listing Superior Healthcare Group, 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.

K925530INSTRUMENT WARMERK924764OVERTUBE FOR ENDSCOPIC LIGATORK905755NON-STERILE PATIENT EXAMINATION GLOVESK903347SODIUM CHLORIDE SOLUTIONK903340STERILE URETHRAL CATHETER PROCEDURE KITSK896321NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.

View all 14 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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