The following data is part of a premarket notification filed by Hydrox Laboratories with the FDA for Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 Ml Bottle.
| Device ID | K974758 |
| 510k Number | K974758 |
| Device Name: | HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE |
| Classification | Catheter And Tip, Suction |
| Applicant | HYDROX LABORATORIES 825 B TOLLGATE RD. Elgin, IL 60123 |
| Contact | Kappana Ramanandan |
| Correspondent | Kappana Ramanandan HYDROX LABORATORIES 825 B TOLLGATE RD. Elgin, IL 60123 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-09 |