L.T.C. REPLACEMENT GASTROSTOMY TUBE
Device Facts
| Record ID | K896621 |
|---|---|
| Device Name | L.T.C. REPLACEMENT GASTROSTOMY TUBE |
| Applicant | Intl. Medical Marketing, Inc. |
| Product Code | KCQ · Dental |
| Decision Date | Mar 13, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.
