The following data is part of a premarket notification filed by Ginsberg Scientific, Inc. with the FDA for Mules Sphere Glass (several Sizes).
Device ID | K895908 |
510k Number | K895908 |
Device Name: | MULES SPHERE GLASS (SEVERAL SIZES) |
Classification | Implant, Eye Sphere |
Applicant | GINSBERG SCIENTIFIC, INC. ROUTE 2, BOX 290 Macks Creek, MO 65786 |
Contact | Edith L Wilson |
Correspondent | Edith L Wilson GINSBERG SCIENTIFIC, INC. ROUTE 2, BOX 290 Macks Creek, MO 65786 |
Product Code | HPZ |
CFR Regulation Number | 886.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-10 |
Decision Date | 1990-01-08 |