The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale Tracheostomy Tube Holder With Trach Mask Attachment Tabs.
| Device ID | K951491 |
| 510k Number | K951491 |
| Device Name: | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Egidia M Vergano |
| Correspondent | Egidia M Vergano DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-31 |
| Decision Date | 1995-04-24 |