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FDA 510(k)

3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION

K-Number: K820460 · 1982-03-08

ApplicantSuperior Plastic Products Corp.
Decision Date1982-03-08
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Superior Plastic Products Corp.. It received FDA 510(k) clearance on 1982-03-08 under 510(k) number K820460. 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 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION?

3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is Superior Plastic Products Corp.. The 510(k) number is K820460.

When did 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION receive FDA 510(k) clearance?

3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION received FDA 510(k) clearance on 1982-03-08, under 510(k) number K820460.

Who is the listed applicant for 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION?

The FDA 510(k) record lists Superior Plastic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION?

The FDA product code for 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION is JOL.

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Other records listing Superior Plastic Products Corp. 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.

K851981NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.K8439759 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FEK841945ENTERAL FEEDING BOTTLEK841630ENTERAL NUTRITION PUMPK840323SILICONE SUCTION & IRRIGATION DRAINK840324SILICONE SUMP DRAIN 20 & 40 FRENCH

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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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