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 |