Cleared Traditional

K781343 - RESURFACE PROSHESIS
(FDA 510(k) Clearance)

K781343 · Aesculap Instruments Corp. · Orthopedic device
Sep 1978
Decision
54d
Days
—
Risk

K781343 is an FDA 510(k) clearance for the RESURFACE PROSHESIS..

Submitted by Aesculap Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978, 54 days after receiving the submission on August 4, 1978.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K781343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1978
Decision Date September 27, 1978
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code —
Device Class —