The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale Endotracheal Tube Holder 270/280.
| Device ID | K964399 |
| 510k Number | K964399 |
| Device Name: | DALE ENDOTRACHEAL TUBE HOLDER 270/280 |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Sharon M Steeves |
| Correspondent | Sharon M Steeves 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 | 1996-11-04 |
| Decision Date | 1997-01-28 |