The following data is part of a premarket notification filed by Mentor Ophthalmics, Inc. with the FDA for Mentor Super Absorbent Drape.
| Device ID | K973146 |
| 510k Number | K973146 |
| Device Name: | MENTOR SUPER ABSORBENT DRAPE |
| Classification | Drape, Surgical |
| Applicant | MENTOR OPHTHALMICS, INC. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR OPHTHALMICS, INC. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-22 |
| Decision Date | 1997-12-04 |
| Summary: | summary |