The following data is part of a premarket notification filed by Jrm Ent., Inc. with the FDA for Tohp-cap.
| Device ID | K941031 |
| 510k Number | K941031 |
| Device Name: | TOHP-CAP |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JRM ENT., INC. 90 EMERSON ST. Boston, MA 02127 |
| Contact | John Mccarthy |
| Correspondent | John Mccarthy JRM ENT., INC. 90 EMERSON ST. Boston, MA 02127 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1995-01-26 |