The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Lopez-horn Carrier.
Device ID | K831312 |
510k Number | K831312 |
Device Name: | LOPEZ-HORN CARRIER |
Classification | Snake Bite Suction Kit |
Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
Product Code | KYP |
CFR Regulation Number | 880.5740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-22 |
Decision Date | 1983-05-25 |