MARK 500 SYSTEM

FDA 510(k) Premarket Notification · Submission K812416 · Applicant: Kallestad Laboratories, Inc.

Public Record 510(k) Submission Decision Date: 1982-04-08 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K812416.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K812416

Applicant / Sponsor

Kallestad Laboratories, Inc.

Device Name

MARK 500 SYSTEM

Product Code

N/A

Decision Date

1982-04-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

1981-08-24

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.