The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Camino Ventricular Drainage System.
Device ID | K932769 |
510k Number | K932769 |
Device Name: | CAMINO VENTRICULAR DRAINAGE SYSTEM |
Classification | Shunt, Central Nervous System And Components |
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 | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-08 |
Decision Date | 1995-03-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780211082 | K932769 | 000 |
30381780072427 | K932769 | 000 |
10381780071686 | K932769 | 000 |