The following data is part of a premarket notification filed by Microwave Medical Systems, Inc. with the FDA for Peritoneal Dialysis Stystem And Accessories.
| Device ID | K900295 |
| 510k Number | K900295 |
| Device Name: | PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Contact | Richard S Grabowy |
| Correspondent | Richard S Grabowy MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-22 |
| Decision Date | 1990-11-21 |