4 SURE TM RECTAL TUBE
Device Facts
| Record ID | K921852 |
|---|---|
| Device Name | 4 SURE TM RECTAL TUBE |
| Applicant | Boston Pacific Medical, Inc. |
| Product Code | KMO · General Hospital |
| Decision Date | Oct 8, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.
