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 |