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 |