The following data is part of a premarket notification filed by Kingswood Laboratories, Inc. with the FDA for Moi-stir Oral Swabstick(s).
| Device ID | K851026 |
| 510k Number | K851026 |
| Device Name: | MOI-STIR ORAL SWABSTICK(S) |
| Classification | Saliva, Artificial |
| Applicant | KINGSWOOD LABORATORIES, INC. 336 HEATHER DR. Carmel, IN 46032 |
| Contact | Thomas W Mcintyre |
| Correspondent | Thomas W Mcintyre KINGSWOOD LABORATORIES, INC. 336 HEATHER DR. Carmel, IN 46032 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-05-21 |