VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND

Colposcope (and Colpomicroscope)

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Video Colposcope/vertical Rolling Base/swing Arm Stand.

Pre-market Notification Details

• Device ID: K955635
• 510k Number: K955635
• Device Name: VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
• Classification: Colposcope (and Colpomicroscope)
• Applicant: WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Contact: Lawrence E Marocco
• Correspondent: Lawrence E Marocco; WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220
• Product Code: HEX
• CFR Regulation Number: 884.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-11
• Decision Date: 1996-05-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00732094136098	K955635	000
00732094053456	K955635	000