The following data is part of a premarket notification filed by Virtual Ports Ltd with the FDA for Virtual Ports Endoclear System.
Device ID | K080051 |
510k Number | K080051 |
Device Name: | VIRTUAL PORTS ENDOCLEAR SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | VIRTUAL PORTS LTD 31 HAAVODA STREET Binyamina, IL 30500 |
Contact | Yoram Levy |
Correspondent | Yoram Levy VIRTUAL PORTS LTD 31 HAAVODA STREET Binyamina, IL 30500 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-08 |
Decision Date | 2008-03-21 |
Summary: | summary |