The following data is part of a premarket notification filed by Dannoritzer Medizintechnik Gmbh & Co. Kg with the FDA for Dan Monopolar Lap Accessories.
Device ID | K052759 |
510k Number | K052759 |
Device Name: | DAN MONOPOLAR LAP ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DANNORITZER MEDIZINTECHNIK GMBH & CO. KG AMSTEL-320-I Amsterdam, NL 1017ap |
Contact | Angelika Scherp |
Correspondent | Angelika Scherp DANNORITZER MEDIZINTECHNIK GMBH & CO. KG AMSTEL-320-I Amsterdam, NL 1017ap |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-30 |
Decision Date | 2006-06-14 |
Summary: | summary |