The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Camino Ventricular Needle.
Device ID | K920088 |
510k Number | K920088 |
Device Name: | CAMINO VENTRICULAR NEEDLE |
Classification | Cannula, Ventricular |
Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Contact | Marie Aker |
Correspondent | Marie Aker CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Product Code | HCD |
CFR Regulation Number | 882.4060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-08 |
Decision Date | 1992-05-01 |