Cleared Traditional

K951529 - V. MUELLER OBSTETRICAL (OB) FORCEPS (FDA 510(k) Clearance)

Aug 1995
Decision
123d
Days
Class 2
Risk

K951529 is an FDA 510(k) clearance for the V. MUELLER OBSTETRICAL (OB) FORCEPS. This device is classified as a Forceps, Obstetrical (Class II - Special Controls, product code HDA).

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on August 4, 1995, 123 days after receiving the submission on April 3, 1995.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4400.

Submission Details

510(k) Number K951529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date August 04, 1995
Days to Decision 123 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HDA — Forceps, Obstetrical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.4400