The following data is part of a premarket notification filed by Kline Technologies, Ltd. with the FDA for The Kline Applicator.
| Device ID | K823517 |
| 510k Number | K823517 |
| Device Name: | THE KLINE APPLICATOR |
| Classification | Applicator, Vaginal |
| Applicant | KLINE TECHNOLOGIES, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGD |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-29 |
| Decision Date | 1983-01-18 |