The following data is part of a premarket notification filed by Grand Medical Products with the FDA for Tracheostomy Kit.
| Device ID | K963720 |
| 510k Number | K963720 |
| Device Name: | TRACHEOSTOMY KIT |
| Classification | Tracheostomy And Nasal Suctioning Kit |
| Applicant | GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
| Contact | Harvey Weiss |
| Correspondent | Harvey Weiss GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
| Product Code | LRQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-11-27 |