The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Imc 5.0mm Irrigation/aspiration Probe.
| Device ID | K933305 |
| 510k Number | K933305 |
| Device Name: | IMC 5.0MM IRRIGATION/ASPIRATION PROBE |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
| Contact | John Mayall |
| Correspondent | John Mayall INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-10-05 |