The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Injection Aspirating Needles.
| Device ID | K821697 |
| 510k Number | K821697 |
| Device Name: | INJECTION ASPIRATING NEEDLES |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-25 |