Home / 510(k) Clearances / K830354

510(k) K830354

COLORECTAL DILATOR by Cleveland Medical Supply & Services — Product Code FFP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 27, 1983
Date Received: February 3, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dilator, Rectal
Device Class: Class I
Regulation Number: 876.5450
Review Panel: GU
Submission Type