The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Camino Ventricular Transducer Accessory.
Device ID | K930221 |
510k Number | K930221 |
Device Name: | CAMINO VENTRICULAR TRANSDUCER ACCESSORY |
Classification | Device, Monitoring, Intracranial Pressure |
Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Contact | Hazel M Aker |
Correspondent | Hazel M Aker CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Product Code | GWM |
CFR Regulation Number | 882.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-15 |
Decision Date | 1993-04-15 |