FDA 510(k) Premarket Notification K800950: TANIT HOME SUNTANNING UNIT

Submission Details & Decision

Normalized public record details for 510(k) notification K800950.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K800950

Applicant / Sponsor

Tanit, Inc.

Device Name

TANIT HOME SUNTANNING UNIT

Product Code

FTC

Decision Date

1980-06-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

1980-04-23

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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 Information may be outdated or incomplete.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.