The following data is part of a premarket notification filed by Medical Compression Systems (dbn) Ltd. with the FDA for Activecare Sft.
Device ID | K110159 |
510k Number | K110159 |
Device Name: | ACTIVECARE SFT |
Classification | Sleeve, Limb, Compressible |
Applicant | MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 25 A SIRKIN STREET Kfar Saba, IL 44421 |
Contact | Orly Maor |
Correspondent | Orly Maor MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 25 A SIRKIN STREET Kfar Saba, IL 44421 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-19 |
Decision Date | 2011-05-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACTIVECARE SFT 76668524 3639986 Live/Registered |
ZIMMER SURGICAL, INC. 2006-11-06 |