Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450530

FEI Number

1450530

Entity Name

PRISTECH PRODUCTS, INC.

City/State/Country

San Antonio, TX, US

Establishment Address

6952 Fairgrounds Pkwy # 107, San Antonio, TX 78238, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Pristech Products, Inc. (Owner Number: 10042028)

Owner / Operator Contact Address

6952 Fairgrounds Pkwy #107, San Antonio, TX 78238, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K934631

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2012-10-09
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2015-12-29
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-07-07

Official Correspondent

Grant Hassmann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pristech Products, 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450530. Last updated year: 2026. Please use registration number 1450530 when referencing this establishment in official correspondence.