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FDA 510(k)

NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI

K-Number: K925588 · 1993-12-03

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1993-12-03
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1993-12-03 under 510(k) number K925588. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI?

NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI is a medical device that received FDA 510(k) clearance on 1993-12-03. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K925588.

When did NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI receive FDA 510(k) clearance?

NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI received FDA 510(k) clearance on 1993-12-03, under 510(k) number K925588.

Who is the listed applicant for NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI?

The FDA product code for NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI is LDQ.

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Other records listing North American Sterilization & Packaging Co. 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.

K964231NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)K963753NASP TRANSPARENT DRESSINGK962352HYDROGEL SKIN DRESSINGK925593NORTEC STERILE WATER FOR DEVICE IRRIGATIONK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIOK911865NORTEC CONNECTING TUBE SET

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Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., 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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