The following data is part of a premarket notification filed by Del Medical Systems Corp. with the FDA for Msv-2000 Video Imaging System.
Device ID | K942924 |
510k Number | K942924 |
Device Name: | MSV-2000 VIDEO IMAGING SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
Contact | Karl J Weydig |
Correspondent | Karl J Weydig DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-22 |
Decision Date | 1994-10-03 |