MICROFLEX

Microscope, Surgical, General & Plastic Surgery

MOELLER MICROSURGICAL, INC.

The following data is part of a premarket notification filed by Moeller Microsurgical, Inc. with the FDA for Microflex.

Pre-market Notification Details

• Device ID: K942304
• 510k Number: K942304
• Device Name: MICROFLEX
• Classification: Microscope, Surgical, General & Plastic Surgery
• Applicant: MOELLER MICROSURGICAL, INC. 7 INDUSTRIAL PARK Waldwick, NJ 07463
• Contact: Richard W Montegomery
• Correspondent: Richard W Montegomery; MOELLER MICROSURGICAL, INC. 7 INDUSTRIAL PARK Waldwick, NJ 07463
• Product Code: FSO
• CFR Regulation Number: 878.4700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-13
• Decision Date: 1994-06-13