The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Viscodissector.
Device ID | K913530 |
510k Number | K913530 |
Device Name: | LOOK VISCODISSECTOR |
Classification | Unit, Phacofragmentation |
Applicant | LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
Contact | Gary Ainsworth |
Correspondent | Gary Ainsworth LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-08 |
Decision Date | 1991-10-21 |