[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5075]

[Page 380]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5075  Elastic bandage.

    (a) Identification. An elastic bandage is a device consisting of 
either a long flat strip or a tube of elasticized material that is used 
to support and compress a part of a patient's body.
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807. If the 
device is not labeled or otherwise represented as sterile, it also is 
exempt from the good manufacturing practice regulation in part 820, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.