The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Apex Suction Curette.
| Device ID | K871384 |
| 510k Number | K871384 |
| Device Name: | APEX SUCTION CURETTE |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Contact | Larry Inman |
| Correspondent | Larry Inman APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-05-22 |