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FDA 510(k)

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

K-Number: K925161 · 1993-07-21

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1993-07-21
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO 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 1993-07-21 under 510(k) number K925161. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO?

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K925161.

When did NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO receive FDA 510(k) clearance?

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO received FDA 510(k) clearance on 1993-07-21, under 510(k) number K925161.

Who is the listed applicant for NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO?

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 STERILE WATER FOR CATHETER BALLOON INFLATIO?

The FDA product code for NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO is KNY.

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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 DRESSINGK925588NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRIK925593NORTEC STERILE WATER FOR DEVICE IRRIGATIONK911865NORTEC CONNECTING TUBE SET

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Related Devices (Code: KNY)

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.

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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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