The following data is part of a premarket notification filed by Primecare, Inc. with the FDA for Prime Care Neonatal/pediatric Tracheostomy Tube.
| Device ID | K901920 |
| 510k Number | K901920 |
| Device Name: | PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PRIMECARE, INC. 23991 IRONHEAD LN. Laguna Niguel, CA 92677 |
| Contact | Joseph H Bales |
| Correspondent | Joseph H Bales PRIMECARE, INC. 23991 IRONHEAD LN. Laguna Niguel, CA 92677 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-08-17 |