The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Camino Csf Drainage System Model 040.
Device ID | K861961 |
510k Number | K861961 |
Device Name: | CAMINO CSF DRAINAGE SYSTEM MODEL 040 |
Classification | Shunt, Central Nervous System And Components |
Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Contact | Dan Mckay |
Correspondent | Dan Mckay CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-20 |
Decision Date | 1986-08-12 |