SYNTR HEALTH TECHNOLOGIES, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3017791237

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
3017791237
FEI Number
3017791237
Entity Name
SYNTR HEALTH TECHNOLOGIES, INC.
City/State/Country
Irvine, CA, US
Establishment Address
9120 Irvine Center Dr Ste 200, Irvine, CA 92618, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Syntr Health Technologies, Inc. (Owner Number: 10079670)
Owner / Operator Contact Address
9120 Irvine Center Drive Suite 200, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203800
PMA Number
N/A

All Registered Proprietary Names

SyntrFuge System SyntrFuge System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2020-12-17
QKL Lipoaspirate Washing System For Aesthetic Body Contouring General, Plastic Surgery Class 2 878.5040 2024-03-07
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2024-03-07
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2022-01-06

Official Correspondent

Ahmed Zobi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Syntr Health Technologies, Inc.
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
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017791237. Last updated year: 2026. Please use registration number 3017791237 when referencing this establishment in official correspondence.
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