The following data is part of a premarket notification filed by Asa Instruments S.r.l. with the FDA for Saliva Ejector Disposable.
| Device ID | K935616 |
| 510k Number | K935616 |
| Device Name: | SALIVA EJECTOR DISPOSABLE |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | ASA INSTRUMENTS S.R.L. VIA VALENZANA, 4 55050 BOZZANO Massarosa (lucca) Italy, IT |
| Contact | Marie Kinkela |
| Correspondent | Marie Kinkela ASA INSTRUMENTS S.R.L. VIA VALENZANA, 4 55050 BOZZANO Massarosa (lucca) Italy, IT |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-22 |
| Decision Date | 1994-03-21 |