The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Chiroflex Forceps.
Device ID | K903575 |
510k Number | K903575 |
Device Name: | CHIROFLEX FORCEPS |
Classification | Lens, Guide, Intraocular |
Applicant | CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
Contact | Mcjarvey |
Correspondent | Mcjarvey CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1990-12-21 |