The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale Head Band Anesthesia Circuit Tube Holder 1315.
| Device ID | K860583 |
| 510k Number | K860583 |
| Device Name: | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 |
| Classification | Support, Breathing Tube |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Daniel W Mcelaney |
| Correspondent | Daniel W Mcelaney DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-18 |
| Decision Date | 1986-02-21 |