BIOFILM, INC.

FDA Device Registration & Listing · VISTA, CA, US · Registration 2025771

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
2025771
FEI Number
2025771
Entity Name
BIOFILM, INC.
City/State/Country
VISTA, CA, US
Establishment Address
3225 Executive Rdg, VISTA, CA 92081, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
COMBE INCORPORATED (Owner Number: 2412672)
Owner / Operator Contact Address
1101 WESTCHESTER AVE., --, White Plains, NY 10604, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220355
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
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2023-11-17
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2023-11-17
MMS Lubricant, Vaginal, Patient General Hospital Class 1 880.6375 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-11-17

Official Correspondent

Richard Grabarz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COMBE INCORPORATED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1450238 COMBE LABORATORIES, INC. RANTOUL, IL, US
2650087 COMBE PRODUCTS, INC. Bo Mariana, PR, US
2412672 COMBE INCORPORATED White Plains, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K050212 Qualis, Inc. PERSONAL WARMING JELLY 2005-03-17
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025771. Last updated year: 2026. Please use registration number 2025771 when referencing this establishment in official correspondence.
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