Cleared Traditional

BIOTHANE PATIENT RESTRAINT

K991591 · Bioplastics · General Hospital

Jul 1999

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K991591 is an FDA 510(k) clearance for the BIOTHANE PATIENT RESTRAINT, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Bioplastics (N. Ridgeville, US). The FDA issued a Cleared decision on July 29, 1999, 83 days after receiving the submission on May 7, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number	K991591 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 1999
Decision Date	July 29, 1999
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement