The following data is part of a premarket notification filed by Intermedics Intraocular, Inc. with the FDA for Bailey Lens Shooter.
Device ID | K841730 |
510k Number | K841730 |
Device Name: | BAILEY LENS SHOOTER |
Classification | Lens, Guide, Intraocular |
Applicant | INTERMEDICS INTRAOCULAR, INC. P.O. BOX 617 Freeport, TX 77541 |
Contact | Grace Drucker |
Correspondent | Grace Drucker INTERMEDICS INTRAOCULAR, INC. P.O. BOX 617 Freeport, TX 77541 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-25 |
Decision Date | 1984-11-19 |