The following data is part of a premarket notification filed by Pci with the FDA for Pci 2500.
Device ID | K933072 |
510k Number | K933072 |
Device Name: | PCI 2500 |
Classification | Stimulator, Muscle, Powered |
Applicant | PCI COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington Dc 20004-1109, DC 20004 |
Contact | Patricia B Schraeder |
Correspondent | Patricia B Schraeder PCI COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington Dc 20004-1109, DC 20004 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-22 |
Decision Date | 1993-10-28 |