The following data is part of a premarket notification filed by Microwave Medical Systems, Inc. with the FDA for Pdm3 Disinfection System For Peritoneal Dialysis Exchanges, Patient Transfer Set Pts102, Cap, High Temperature.
| Device ID | K974387 |
| 510k Number | K974387 |
| Device Name: | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | MICROWAVE MEDICAL SYSTEMS, INC. 310-312 SCHOOL ST. Acton, MA 01720 |
| Contact | Richard S Grabowy |
| Correspondent | Richard S Grabowy MICROWAVE MEDICAL SYSTEMS, INC. 310-312 SCHOOL ST. Acton, MA 01720 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1999-09-01 |