FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRA DISPOSABLE SPRAY CANNULA
K Number: K894755
·
Decision Jan 12, 1990
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
2
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ASTRA DISPOSABLE SPRAY CANNULA
- K Number
- K894755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5170
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Astra Pharmaceutical Products, Inc.
- Date Received
- July 27, 1989
- Decision Date
- January 12, 1990
- Product Code
- CCT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCT), ordered by most recent decision date.
UltraEzAir® (UEA1A)
FDA 510(k)
FDA Class 2
·Anesthesiology
Medicant Mucosal Atomizer
FDA 510(k)
FDA Class 2
·Anesthesiology
MADgic Laryngo-Tracheal Mucosal Atomization Device
FDA 510(k)
FDA Class 2
·Anesthesiology
EZ-MISTER
FDA 510(k)
FDA Class 2
·Anesthesiology
TOPICAL APPLICATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Astra Pharmaceutical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851903 | ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN | Jul 2, 1985 | Substantially Equivalent |