The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for Tracheostomy Cleansing Solution.
| Device ID | K862563 |
| 510k Number | K862563 |
| Device Name: | TRACHEOSTOMY CLEANSING SOLUTION |
| Classification | Brush, Cleaning, Tracheal Tube |
| Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Contact | Sidney Finkelstein |
| Correspondent | Sidney Finkelstein CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Product Code | EPE |
| CFR Regulation Number | 868.5795 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-07-15 |