The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson Dispos Thoracic Drainage Set - 551-8000.
Device ID | K873489 |
510k Number | K873489 |
Device Name: | EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Contact | George Emerson |
Correspondent | George Emerson J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1987-12-29 |