The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Tenderfoot(r), Modification.
| Device ID | K911997 |
| 510k Number | K911997 |
| Device Name: | TENDERFOOT(R), MODIFICATION |
| Classification | Device, Bleeding Time |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Les Heimann |
| Correspondent | Les Heimann INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JCA |
| CFR Regulation Number | 864.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20711234312022 | K911997 | 000 |
| 20711234303082 | K911997 | 000 |
| 20711234302160 | K911997 | 000 |
| 20711234302153 | K911997 | 000 |
| 20711234302139 | K911997 | 000 |