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 |