The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Thoracic Drainage Set #55-db2-g.
Device ID | K812746 |
510k Number | K812746 |
Device Name: | THORACIC DRAINAGE SET #55-DB2-G |
Classification | Bottle, Collection, Vacuum |
Applicant | J. H. EMERSON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-29 |
Decision Date | 1981-10-26 |