The following data is part of a premarket notification filed by Robert B. Scott Ocularists Of Florida, Inc. with the FDA for Robert B. Scott Plastic Artifical.
Device ID | K952538 |
510k Number | K952538 |
Device Name: | ROBERT B. SCOTT PLASTIC ARTIFICAL |
Classification | Eye, Artificial, Non-custom |
Applicant | ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC. 3500 EAST FLETCHER AVE. SUITE 502 Tampa, FL 33613 |
Contact | Randal E Minor |
Correspondent | Randal E Minor ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC. 3500 EAST FLETCHER AVE. SUITE 502 Tampa, FL 33613 |
Product Code | HQH |
CFR Regulation Number | 886.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-31 |
Decision Date | 1995-06-26 |