MINISCOPE

Arthroscope

CITATION MEDICAL CORP.

The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Miniscope.

Pre-market Notification Details

• Device ID: K910587
• 510k Number: K910587
• Device Name: MINISCOPE
• Classification: Arthroscope
• Applicant: CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502
• Contact: F Waddell
• Correspondent: F Waddell; CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-02-12
• Decision Date: 1991-05-13