The following data is part of a premarket notification filed by Sentek, Inc. with the FDA for Revised T-scan System.
| Device ID | K870032 |
| 510k Number | K870032 |
| Device Name: | REVISED T-SCAN SYSTEM |
| Classification | Paper, Articulation |
| Applicant | SENTEK, INC. THIRD FLOOR 818 CONNECTICUT AVENUE, N.W. Washington, DC 20006 |
| Contact | Stephen A Weitzman |
| Correspondent | Stephen A Weitzman SENTEK, INC. THIRD FLOOR 818 CONNECTICUT AVENUE, N.W. Washington, DC 20006 |
| Product Code | EFH |
| CFR Regulation Number | 872.6140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-02-02 |