The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Solution/test Standard/conduct. Dialy.&mult.solut..
Device ID | K863824 |
510k Number | K863824 |
Device Name: | SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. |
Classification | Solution-test Standard-conductivity, Dialysis |
Applicant | D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Contact | Vincent E Corsano |
Correspondent | Vincent E Corsano D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Product Code | FKH |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-30 |
Decision Date | 1986-10-24 |