The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Tracheostomy Masks/adult & Paediatric.
| Device ID | K860871 |
| 510k Number | K860871 |
| Device Name: | TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC |
| Classification | Mask, Oxygen |
| Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
| Contact | Ronald N Mchenry |
| Correspondent | Ronald N Mchenry DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-03-19 |