The following data is part of a premarket notification filed by Daniel T Acosta with the FDA for Custom Artificial Human Eyes.
Device ID | K945270 |
510k Number | K945270 |
Device Name: | CUSTOM ARTIFICIAL HUMAN EYES |
Classification | Eye, Artificial, Non-custom |
Applicant | DANIEL T ACOSTA 2244 FOURTH AVE., SUITE E San Diego, CA 92101 |
Contact | Daniel T Acosta |
Correspondent | Daniel T Acosta DANIEL T ACOSTA 2244 FOURTH AVE., SUITE E San Diego, CA 92101 |
Product Code | HQH |
CFR Regulation Number | 886.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-28 |
Decision Date | 1995-05-30 |