Cleared Traditional

K933770 - FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
(FDA 510(k) Clearance)

K933770 · Mahe-Medizintechnik · Ear, Nose, Throat device

Mar 1994

Decision

237d

Days

Class 1

Risk

K933770 is an FDA 510(k) clearance for the FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on March 23, 1994, 237 days after receiving the submission on July 29, 1993.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K933770 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1993
Decision Date	March 23, 1994
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement