The following data is part of a premarket notification filed by Polytouch Medical Ltd with the FDA for Patchassist Large.
| Device ID | K103269 |
| 510k Number | K103269 |
| Device Name: | PATCHASSIST LARGE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-04 |
| Decision Date | 2010-11-23 |
| Summary: | summary |