The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson Tro/cath Trocar Catheters.
Device ID | K853132 |
510k Number | K853132 |
Device Name: | EMERSON TRO/CATH TROCAR CATHETERS |
Classification | Trocar |
Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Contact | George P Emerson |
Correspondent | George P Emerson J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Product Code | DRC |
CFR Regulation Number | 870.1390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-26 |
Decision Date | 1986-01-08 |