The following data is part of a premarket notification filed by Dadsun Corp., Ltd. with the FDA for Various Adult & Child High Con/nonrebreath Oxy Masks.
| Device ID | K953039 |
| 510k Number | K953039 |
| Device Name: | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS |
| Classification | Mask, Oxygen |
| Applicant | DADSUN CORP., LTD. P.O. BOX 73-30 Taipei, TW |
| Contact | Jimmy Wang |
| Correspondent | Jimmy Wang DADSUN CORP., LTD. P.O. BOX 73-30 Taipei, TW |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-13 |
| Decision Date | 1995-09-15 |