The following data is part of a premarket notification filed by Ocular Sciences Puerto Rico, Inc. with the FDA for Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens.
| Device ID | K972303 |
| 510k Number | K972303 |
| Device Name: | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCULAR SCIENCES PUERTO RICO, INC. 22210 QUINTERNO CT. Cupertino, CA 95014 |
| Contact | David Marcus |
| Correspondent | David Marcus OCULAR SCIENCES PUERTO RICO, INC. 22210 QUINTERNO CT. Cupertino, CA 95014 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-19 |
| Decision Date | 1997-08-20 |
| Summary: | summary |