510(k) K894755

ASTRA DISPOSABLE SPRAY CANNULA by Astra Pharmaceutical Products, Inc. — Product Code CCT

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