The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Ross-emerson Pump, Model 55-r.
Device ID | K811779 |
510k Number | K811779 |
Device Name: | ROSS-EMERSON PUMP, MODEL 55-R |
Classification | Evacuator, Gastro-urology |
Applicant | J. H. EMERSON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQT |
CFR Regulation Number | 876.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-23 |
Decision Date | 1981-07-13 |