MEDSCOPE

Colposcope (and Colpomicroscope)

ALL-PRO IMAGING CORP.

The following data is part of a premarket notification filed by All-pro Imaging Corp. with the FDA for Medscope.

Pre-market Notification Details

• Device ID: K001314
• 510k Number: K001314
• Device Name: MEDSCOPE
• Classification: Colposcope (and Colpomicroscope)
• Applicant: ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801
• Contact: Joseph Carey
• Correspondent: Joseph Carey; ALL-PRO IMAGING CORP. 70 CANTIAGUE ROCK RD. P.O. BOX 870 Hicksville, NY 11801
• Product Code: HEX
• CFR Regulation Number: 884.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-26
• Decision Date: 2000-07-25