PHYSICIAN'S CHOICE

Speculum, Vaginal, Nonmetal

ADVANCE MEDICAL DEVICE, INC.

The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Physician's Choice.

Pre-market Notification Details

• Device ID: K903744
• 510k Number: K903744
• Device Name: PHYSICIAN'S CHOICE
• Classification: Speculum, Vaginal, Nonmetal
• Applicant: ADVANCE MEDICAL DEVICE, INC. 15 VALLEY TRAIL, R.R. #1, NEWMARKET, Ontario L3y 4v8, Canada, CA
• Contact: Robert G Dickie
• Correspondent: Robert G Dickie; ADVANCE MEDICAL DEVICE, INC. 15 VALLEY TRAIL, R.R. #1, NEWMARKET, Ontario L3y 4v8, Canada, CA
• Product Code: HIB
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-08-16
• Decision Date: 1990-09-12