The following data is part of a premarket notification filed by J.h.orsing Ab with the FDA for Hygoflex Saliva-ejector.
| Device ID | K935758 |
| 510k Number | K935758 |
| Device Name: | HYGOFLEX SALIVA-EJECTOR |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | J.H.ORSING AB P.O. BOX 16077 TORBORNAVAGEN 26 Raa, SE S-25016 |
| Contact | Kerstin Orsing |
| Correspondent | Kerstin Orsing J.H.ORSING AB P.O. BOX 16077 TORBORNAVAGEN 26 Raa, SE S-25016 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-03-21 |