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 |