KAL-MED, LLC.

FDA Device Registration & Listing · KENSINGTON, CT, US · Registration 3006024395

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
3006024395
FEI Number
3006024395
Entity Name
KAL-MED, LLC.
City/State/Country
KENSINGTON, CT, US
Establishment Address
570 Percival Ave, KENSINGTON, CT 06037, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device
Owner / Operator
KAL-MED LLC (Owner Number: 9094679)
Owner / Operator Contact Address
570 PERCIVAL AVENUE, --, Kensington, CT 06037, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K191858
PMA Number
N/A

All Registered Proprietary Names

Scanhead protection cover Clip-On Biteguard Tubeguard PYLANT MONITOR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2010-11-21
BSK Cuff, Tracheal Tube, Inflatable Anesthesiology Class 2 868.5750 2020-03-12

Official Correspondent

Robert Kaliski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KAL-MED LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2014 H & H Associates 2
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006024395. Last updated year: 2026. Please use registration number 3006024395 when referencing this establishment in official correspondence.
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