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 |