The following data is part of a premarket notification filed by Micromed Development Corp. with the FDA for Disposable Joint Aspiration/injection Diagnostic Kit.
| Device ID | K945831 |
| 510k Number | K945831 |
| Device Name: | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT |
| Classification | General Surgery Tray |
| Applicant | MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dan H Treace |
| Correspondent | Dan H Treace MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-01-20 |