The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsino Tracheostomy Care Tray.
| Device ID | K023276 |
| 510k Number | K023276 |
| Device Name: | AMSINO TRACHEOSTOMY CARE TRAY |
| Classification | General Surgery Tray |
| Applicant | AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario, CA 91761 |
| Contact | Dean R Gauf |
| Correspondent | Dean R Gauf AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario, CA 91761 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-12-09 |