The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Thoro/cath Straight Thoracic Right Angle.
| Device ID | K853131 |
| 510k Number | K853131 |
| Device Name: | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Contact | George P Emersomn |
| Correspondent | George P Emersomn J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-26 |
| Decision Date | 1985-09-05 |