GYNESCOPE

Colposcope (and Colpomicroscope)

MEDGYN PRODUCTS, INC.

The following data is part of a premarket notification filed by Medgyn Products, Inc. with the FDA for Gynescope.

Pre-market Notification Details

• Device ID: K880195
• 510k Number: K880195
• Device Name: GYNESCOPE
• Classification: Colposcope (and Colpomicroscope)
• Applicant: MEDGYN PRODUCTS, INC. 2808 A. CENTER CIRCLE Downers Grove, IL 60515
• Contact: Lakshman Agadi
• Correspondent: Lakshman Agadi; MEDGYN PRODUCTS, INC. 2808 A. CENTER CIRCLE Downers Grove, IL 60515
• Product Code: HEX
• CFR Regulation Number: 884.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-01-26
• Decision Date: 1988-03-14