The following data is part of a premarket notification filed by Polytouch Medical Ltd with the FDA for Patchassist.
Device ID | K101218 |
510k Number | K101218 |
Device Name: | PATCHASSIST |
Classification | Mesh, Surgical, Deployer |
Applicant | POLYTOUCH MEDICAL LTD 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
Contact | Leo Basta |
Correspondent | Leo Basta POLYTOUCH MEDICAL LTD 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
Product Code | ORQ |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-30 |
Decision Date | 2010-06-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATCHASSIST 85076905 not registered Dead/Abandoned |
TYCO HEALTHCARE GROUP LP 2010-07-02 |
PATCHASSIST 79259355 not registered Dead/Abandoned |
ELDI Handels GmbH 2018-11-20 |