The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Throat-a-scope.
| Device ID | K923227 |
| 510k Number | K923227 |
| Device Name: | THROAT-A-SCOPE |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Contact | Emanuel A Rosen |
| Correspondent | Emanuel A Rosen TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1992-12-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THROAT-A-SCOPE 74387548 1951693 Dead/Cancelled |
TRUPHATEK INTERNATIONAL LIMITED 1993-05-03 |