Question 1

Who is the manufacturer of CITATION POWER TOOL?

Accepted Answer

Citation Medical Corp. filed the 510(k) submission for CITATION POWER TOOL (K946290).

Question 2

What is the FDA product code for CITATION POWER TOOL?

Accepted Answer

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

Question 3

When was CITATION POWER TOOL cleared by the FDA?

Accepted Answer

Jun 15, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for CITATION POWER TOOL?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like CITATION POWER TOOL?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K946290
Device Name	CITATION POWER TOOL
Applicant	Citation Medical Corp.
Product Code	HRX · Orthopedic
Decision Date	Jun 15, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

CITATION POWER TOOL

Device Facts

Regulatory Classification

Identification