The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Cardiovations Portable Video System.
Device ID | K032339 |
510k Number | K032339 |
Device Name: | CARDIOVATIONS PORTABLE VIDEO SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
Contact | Peter Cecchini |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-07-29 |
Decision Date | 2003-08-08 |
Summary: | summary |