FDA 510(k) Premarket Notification K812396: ARTHRO-PREP REST

Submission Details & Decision

Normalized public record details for 510(k) notification K812396.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K812396

Applicant / Sponsor

Northwest Surgical Concepts, Inc.

Device Name

ARTHRO-PREP REST

Product Code

BWN

Decision Date

1981-11-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

1981-08-20

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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 Information may be outdated or incomplete.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.