FFP · Class I · 21 CFR 876.5450

FDA Product Code FFP: Dilator, Rectal

Leading manufacturers include Telemed Systems, Inc. and Mk Conquest Intl., Inc..

5
Total
5
Cleared
181d
Avg days
1983
Since

FDA 510(k) Cleared Dilator, Rectal Devices (Product Code FFP)

5 devices
1–5 of 5
Cleared Jun 06, 1997
ANOKRYO
K964634
Mk Conquest Intl., Inc.
Gastroenterology & Urology · 199d
Cleared Jun 21, 1990
COLONIC BALLOON DILATOR
K901426
Telemed Systems, Inc.
Gastroenterology & Urology · 87d

About Product Code FFP - Regulatory Context