The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Coron Pres Monitor Kit Model 80 Left Kit Model 90.
| Device ID | K853072 |
| 510k Number | K853072 |
| Device Name: | CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-12-09 |