Cleared Traditional

4 SURE TM RECTAL TUBE

K921852 · Boston Pacific Medical, Inc. · General Hospital
Oct 1993
Decision
539d
Days
Class 1
Risk

About This 510(k) Submission

K921852 is an FDA 510(k) clearance for the 4 SURE TM RECTAL TUBE, a Binder, Elastic (Class I — General Controls, product code KMO), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on October 8, 1993, 539 days after receiving the submission on April 17, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5160.

Submission Details

510(k) Number K921852 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1992
Decision Date October 08, 1993
Days to Decision 539 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KMO — Binder, Elastic
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5160