Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1925276

FEI Number

1925276

Entity Name

HTI Plastics, a Division of PCE Inc.

City/State/Country

Lincoln, NE, US

Establishment Address

5120 N.W. 38TH ST., Lincoln, NE 68524, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HTI Plastics, a Division of PCE. (Owner Number: 1925276)

Owner / Operator Contact Address

5120 N.W. 38TH ST., --, Lincoln, NE 68524, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Applicator, Vaginal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1992-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HTI Plastics, a Division of PCE.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1925276. Last updated year: 2026. Please use registration number 1925276 when referencing this establishment in official correspondence.