The following data is part of a premarket notification filed by Carlisle Laboratories, Inc. with the FDA for Saliva Ejector.
| Device ID | K861934 |
| 510k Number | K861934 |
| Device Name: | SALIVA EJECTOR |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood, NY 11696 |
| Contact | Michael Stehn |
| Correspondent | Michael Stehn CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood, NY 11696 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-09 |