SYLKE, INC.

FDA Device Registration & Listing · La Jolla, CA, US · Registration 3029335425

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
3029335425
FEI Number
3029335425
Entity Name
SYLKE, INC.
City/State/Country
La Jolla, CA, US
Establishment Address
4150 Regents Park Row, STE 300, La Jolla, CA 92037, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Sylke, Inc. (Owner Number: 10088767)
Owner / Operator Contact Address
4150 Regents Park Row, STE 300, La Jolla, CA 92037, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SYLKE Skin Closure (24cm x 3.4cm) SYLKE Adhesive Wound Closure (16cm x 2.5cm) SYLKE Adhesive Wound Closure (24cm x 3.4cm) SYLKE Skin Closure (16cm x 2.5cm) SYLKE Adhesive Wound Closure (32cm x 2.5cm) SYLKE Skin Closure (32cm x 2.5cm)

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 2023-10-09

Official Correspondent

Mehrdad Mofid

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sylke, 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 3029335425. Last updated year: 2026. Please use registration number 3029335425 when referencing this establishment in official correspondence.
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