The following data is part of a premarket notification filed by Ocular Sciences Puerto Rico, Inc. with the FDA for Ocular Sciences, Inc., Biomedics 60 (ocufilcon F) Uv Blocking Daily Wear Soft Contact Lens.
Device ID | K992264 |
510k Number | K992264 |
Device Name: | OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | OCULAR SCIENCES PUERTO RICO, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
Contact | Richard E Lippman |
Correspondent | Richard E Lippman OCULAR SCIENCES PUERTO RICO, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-06 |
Decision Date | 1999-11-24 |
Summary: | summary |