The following data is part of a premarket notification filed by Jane I. Kundin with the FDA for Kundin Wound Gauge.
| Device ID | K863409 |
| 510k Number | K863409 |
| Device Name: | KUNDIN WOUND GAUGE |
| Classification | Tape, Measuring, Rulers And Calipers |
| Applicant | JANE I. KUNDIN 1288 LAUREL HILL DR. San Mateo, CA 94402 |
| Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-09-29 |