The following data is part of a premarket notification filed by General Medical Mfg. Co. with the FDA for Pd-pak.
| Device ID | K933619 |
| 510k Number | K933619 |
| Device Name: | PD-PAK |
| Classification | Warmer, Peritoneal Dialysate |
| Applicant | GENERAL MEDICAL MFG. CO. 8741 LANDMARK RD. Richmond, VA 23228 |
| Contact | Alfred H Grebe |
| Correspondent | Alfred H Grebe GENERAL MEDICAL MFG. CO. 8741 LANDMARK RD. Richmond, VA 23228 |
| Product Code | MLW |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1994-02-22 |