The following data is part of a premarket notification filed by Astra Pharmaceutical Products, Inc. with the FDA for Astra Disposable Spray Cannula.
| Device ID | K894755 |
| 510k Number | K894755 |
| Device Name: | ASTRA DISPOSABLE SPRAY CANNULA |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | ASTRA PHARMACEUTICAL PRODUCTS, INC. 50 OTIS ST. Westborough, MA 01581 |
| Contact | David J Pizzi |
| Correspondent | David J Pizzi ASTRA PHARMACEUTICAL PRODUCTS, INC. 50 OTIS ST. Westborough, MA 01581 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1990-01-12 |