The following data is part of a premarket notification filed by Dadsun Corp., Ltd. with the FDA for Carnation Tracheostomy Masks.
| Device ID | K894457 |
| 510k Number | K894457 |
| Device Name: | CARNATION TRACHEOSTOMY MASKS |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | DADSUN CORP., LTD. P.O. BOX 73-30 Taipei, TW |
| Contact | Henry Chen |
| Correspondent | Henry Chen DADSUN CORP., LTD. P.O. BOX 73-30 Taipei, TW |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-10-13 |