The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Hand Surgery And Irrigation Tray (model 3625).
Device ID | K900376 |
510k Number | K900376 |
Device Name: | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) |
Classification | Tray, Surgical, Instrument |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | John Dockter |
Correspondent | John Dockter PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-26 |
Decision Date | 1990-04-10 |