The following data is part of a premarket notification filed by Continental Medical Laboratories, Inc. with the FDA for Tracheostomy Cleaning Tray W/suction Catheter.
| Device ID | K962078 |
| 510k Number | K962078 |
| Device Name: | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | CONTINENTAL MEDICAL LABORATORIES, INC. 817 W.MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn CONTINENTAL MEDICAL LABORATORIES, INC. 817 W.MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-10-11 |