The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Tenderlett Finger.
| Device ID | K923302 |
| 510k Number | K923302 |
| Device Name: | TENDERLETT FINGER |
| Classification | Lancet, Blood |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Matt Lesnieski |
| Correspondent | Matt Lesnieski INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1993-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20711234308186 | K923302 | 000 |
| 20711234308162 | K923302 | 000 |