Cleared Traditional

PAVLIK HARNESS

K780375 · Biomet, Inc. · Physical Medicine
Mar 1978
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K780375 is an FDA 510(k) clearance for the PAVLIK HARNESS, a Splint, Abduction, Congenital Hip Dislocation (Class I — General Controls, product code IOZ), submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978, 7 days after receiving the submission on March 8, 1978. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3665.

Submission Details

510(k) Number K780375 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1978
Decision Date March 15, 1978
Days to Decision 7 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOZ — Splint, Abduction, Congenital Hip Dislocation
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3665