The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Tracheostomy Care Kit.
| Device ID | K910362 |
| 510k Number | K910362 |
| Device Name: | TRACHEOSTOMY CARE KIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| Contact | Ellen Joy |
| Correspondent | Ellen Joy MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-04-08 |