The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Arthroscopy Pump, Model A107.
Device ID | K030402 |
510k Number | K030402 |
Device Name: | ARTHROSCOPY PUMP, MODEL A107 |
Classification | Arthroscope |
Applicant | W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge, MA 02138 |
Contact | Susanne Raab |
Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge, MA 02138 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-06 |
Decision Date | 2003-04-17 |
Summary: | summary |