The following data is part of a premarket notification filed by Op-d-op Visor Shields, Inc. with the FDA for Op-d-op Ii.
| Device ID | K945098 |
| 510k Number | K945098 |
| Device Name: | OP-D-OP II |
| Classification | Accessory, Surgical Apparel |
| Applicant | OP-D-OP VISOR SHIELDS, INC. 8559 WASHINGTON BLVD. Roseville, CA 95678 |
| Contact | Tim Landis |
| Correspondent | Tim Landis OP-D-OP VISOR SHIELDS, INC. 8559 WASHINGTON BLVD. Roseville, CA 95678 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-02-28 |