The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Floguard, Model 6050.
| Device ID | K992785 |
| 510k Number | K992785 |
| Device Name: | IBC FLOGUARD, MODEL 6050 |
| Classification | Cpb Check Valve, Retrograde Flow, In-line |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Contact | H. David Shockley, Jr |
| Correspondent | H. David Shockley, Jr INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Product Code | MJJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 2000-01-14 |
| Summary: | summary |