510(k) K860583
K860583 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315". The FDA issued a decision of Substantially Equivalent on February 21, 1986. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1986
- Date Received
- February 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type