510(k) K894755
K894755 is an FDA 510(k) premarket notification submitted by Astra Pharmaceutical Products, Inc. for the device "ASTRA DISPOSABLE SPRAY CANNULA". The FDA issued a decision of Substantially Equivalent on January 12, 1990. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Astra Pharmaceutical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1990
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5170
- Review Panel
- AN
- Submission Type