The following data is part of a premarket notification filed by Bova Intl. with the FDA for Klaas Iol Lensfolder.
Device ID | K930628 |
510k Number | K930628 |
Device Name: | KLAAS IOL LENSFOLDER |
Classification | Lens, Guide, Intraocular |
Applicant | BOVA INTL. 2217 SIXTH AVE. Fort Worth, TX 76116 |
Contact | Bodo Oehler |
Correspondent | Bodo Oehler BOVA INTL. 2217 SIXTH AVE. Fort Worth, TX 76116 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-08 |
Decision Date | 1995-02-07 |