The following data is part of a premarket notification filed by Smart Medical Systems, Ltd. with the FDA for Naviaid Balloon Guided Colonoscopy (bgc) Device.
Device ID | K102616 |
510k Number | K102616 |
Device Name: | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
Contact | Adva Yoselzon |
Correspondent | Adva Yoselzon SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-10 |
Decision Date | 2010-12-30 |
Summary: | summary |