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 |