The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale I.v. Identifier; Product #1125.
| Device ID | K894586 |
| 510k Number | K894586 |
| Device Name: | DALE I.V. IDENTIFIER; PRODUCT #1125 |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Daniel Mcelaney |
| Correspondent | Daniel Mcelaney DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-08-15 |