FDA 510(k) Premarket Notification K851213: ZWEYMULLER CUP

Submission Details & Decision

Normalized public record details for 510(k) notification K851213.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K851213

Applicant / Sponsor

Allo Pro Corp.

Device Name

ZWEYMULLER CUP

Product Code

KWA

Decision Date

1985-05-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-03-26

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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 Information may be outdated or incomplete.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.