Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016965604

FEI Number

3016965604

Entity Name

CALLA HEALTH FOUNDATION

City/State/Country

Durham, NC, US

Establishment Address

701 W Main St Ste 200, Durham, NC 27701, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Calla Health Foundation (Owner Number: 10075188)

Owner / Operator Contact Address

701 W. Main Street, Suite 200, Durham, NC 27701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181034

PMA Number

N/A

All Registered Proprietary Names

Pocket Colposcope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2020-06-08

Official Correspondent

Marlee Krieger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Calla Health Foundation

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 3016965604. Last updated year: 2026. Please use registration number 3016965604 when referencing this establishment in official correspondence.