The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Acid Fuchsin Solutions.
Device ID | K870889 |
510k Number | K870889 |
Device Name: | ACID FUCHSIN SOLUTIONS |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Contact | Adolph E D'amico |
Correspondent | Adolph E D'amico D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-05 |
Decision Date | 1987-07-08 |