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FDA 510(k)

APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY

K-Number: K873563 · 1987-11-23

ApplicantAplicare, Inc.
Decision Date1987-11-23
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY is the device name listed in this FDA 510(k) record. The listed applicant is Aplicare, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K873563. 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 APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY?

APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Aplicare, Inc.. The 510(k) number is K873563.

When did APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY receive FDA 510(k) clearance?

APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY received FDA 510(k) clearance on 1987-11-23, under 510(k) number K873563.

Who is the listed applicant for APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY?

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

What is the FDA product code for APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY?

The FDA product code for APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY is JOL.

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Other records listing Aplicare, 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.

K923299APLICARE ONE COMPUND BENZION TINCTURE SWABSTICKK895039STERILE SALINE - FOR SUCTION CATHETER LUBRICATIONK861557APLICARE SKIN PROTECTANT PREP PADK861558APLICARE SKIN PROTECTANT SWABSTICKK833185ACETONE ALCOHOL PREP PADK833183APLICARE ONE ACETONE ALCOHOL SWABSTICK

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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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