The following data is part of a premarket notification filed by Hans Hermann Gmbh with the FDA for Hans Hermann Laparoscopes And Accessories.
Device ID | K051610 |
510k Number | K051610 |
Device Name: | HANS HERMANN LAPAROSCOPES AND ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | HANS HERMANN GMBH UNTERER WINKEL 3 Wurmlingen, DE D-78567 |
Contact | Harald Jung |
Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-06-17 |
Decision Date | 2005-07-29 |
Summary: | summary |