Cleared Traditional

NUCLEOTOME

K844131 · Medical Instrument Development Laboratories, Inc. · Orthopedic

Nov 1984

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K844131 is an FDA 510(k) clearance for the NUCLEOTOME, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on November 29, 1984, 37 days after receiving the submission on October 23, 1984. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K844131 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1984
Decision Date	November 29, 1984
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820