SPIRAIR, INC

FDA Device Registration & Listing · South San Francisco, CA, US · Registration 3030653921

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030653921
FEI Number
3030653921
Entity Name
SPIRAIR, INC
City/State/Country
South San Francisco, CA, US
Establishment Address
415 Grand Avenue, Suite 201, South San Francisco, CA 94080, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Spirair, Inc (Owner Number: 10090843)
Owner / Operator Contact Address
415 Grand Avenue, Suite 201, South San Francisco, CA 94080, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233569
PMA Number
N/A

All Registered Proprietary Names

TurbAlign SeptAlign

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2025-08-26
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2024-05-31

Official Correspondent

Tracey Henry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spirair, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3043562110 Spirair Mountain View, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030653921. Last updated year: 2026. Please use registration number 3030653921 when referencing this establishment in official correspondence.
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