Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030616

FEI Number

3000207077

Entity Name

HI-TECH PRODUCTS INC.

City/State/Country

Buena Park, CA, US

Establishment Address

8530 Roland St, Buena Park, CA 90621, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hi-Tech Products Inc. (Owner Number: 10045089)

Owner / Operator Contact Address

8530 Roland St, Buena Park, CA 90621, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DaisyDot BioButton Rechargeable Adhesive; Cold Seal BioButton Rechargeable Adhesive SYLKE Adhesive Wound Closure (16cm x 2.5cm); SYLKE Adhesive Wound Closure (24cm x 3.4cm); SYLKE Adhesive Wound Closure ( Finess

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-10-30
MNG	External Urethral Occluder, Urinary Incontinence-Control, Female	Gastroenterology, Urology	Class 1	876.5160	2018-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hi-Tech 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030616. Last updated year: 2026. Please use registration number 2030616 when referencing this establishment in official correspondence.