The following data is part of a premarket notification filed by U.s. Medical Corp. with the FDA for U.s. Medical Ps-7000 Dialysis Scale.
Device ID | K924440 |
510k Number | K924440 |
Device Name: | U.S. MEDICAL PS-7000 DIALYSIS SCALE |
Classification | Dilator, Urethral |
Applicant | U.S. MEDICAL CORP. 12 SCOVIL RD. Higgaum, CT 06441 |
Contact | Bruce E Dodson |
Correspondent | Bruce E Dodson U.S. MEDICAL CORP. 12 SCOVIL RD. Higgaum, CT 06441 |
Product Code | KOE |
CFR Regulation Number | 876.5520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1993-05-26 |