Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015468759

FEI Number

3015468759

Entity Name

SYNTECH DE BAJA CALIFORNIA, S De RL DE CV

City/State/Country

Col. San Antonio Oeste Mexico, MX

Establishment Address

Blvd. Federico Benetiz 15334-1A, Col. San Antonio Oeste Mexico 22114, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Syntech De Baja California (Owner Number: 10025436)

Owner / Operator Contact Address

17171 daimler, ave, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MaxAir Surgical Helmet System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-05-03

Official Correspondent

Nick Herbert

US Agent Details

Eric Fiskewold Email: efiskewoldsyntech@gmail.com Phone: (949) 7529642

Related Public Records

Same Entity

Syntech De Baja California

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015468759. Last updated year: 2026. Please use registration number 3015468759 when referencing this establishment in official correspondence.