The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Gill's Irrigator/aspirator Needle.
| Device ID | K843925 |
| 510k Number | K843925 |
| Device Name: | GILL'S IRRIGATOR/ASPIRATOR NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Carl A Angles |
| Correspondent | Carl A Angles CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-05 |
| Decision Date | 1984-11-05 |