The following data is part of a premarket notification filed by X-tech Medical, Llc. with the FDA for Sof-suction Fluid Evacuation System.
| Device ID | K990749 |
| 510k Number | K990749 |
| Device Name: | SOF-SUCTION FLUID EVACUATION SYSTEM |
| Classification | Sponge, Ophthalmic |
| Applicant | X-TECH MEDICAL, LLC. 111 WILD OAK COURT Danville, CA 94506 |
| Contact | Edgar A Rainin |
| Correspondent | Edgar A Rainin X-TECH MEDICAL, LLC. 111 WILD OAK COURT Danville, CA 94506 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-04-02 |
| Summary: | summary |