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FDA 510(k)

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY

K-Number: K911784 · 1991-09-23

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1991-09-23
Product CodeBTQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY 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 1991-09-23 under 510(k) number K911784. The device is classified under product code BTQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY?

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K911784.

When did NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY receive FDA 510(k) clearance?

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY received FDA 510(k) clearance on 1991-09-23, under 510(k) number K911784.

Who is the listed applicant for NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY?

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 ROBERTAZZI NASOPHARYNGEAL AIRWAY?

The FDA product code for NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY is BTQ.

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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 IRRIGATIONK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

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Related Devices (Code: BTQ)

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.

K940320AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGSAd-Tech Medical Instrument CorpK921353NASOPHARYNGEAL AIRWAYCoast Medical Corp.K903618ROBERTAZZI NASOPHARYNGEAL AIRWAYEastmed Enterprises, Inc.K900456POLAMEDCO NASOPAHARYNGEAL AIRWAYPolamedco, Inc.K901279CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAYChatham IndustriesK883668SUNDERLAND NASAL TUBEExmoor Plastics , Ltd.

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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