The following data is part of a premarket notification filed by Endoservice Optical Instruments Gmbh with the FDA for Endoservice Endoscopic Instruments & Accessories And Minimally Invasive Gi And Gu Devices.
| Device ID | K113062 |
| 510k Number | K113062 |
| Device Name: | ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES |
| Classification | Telescope, Rigid, Endoscopic |
| Applicant | ENDOSERVICE OPTICAL INSTRUMENTS GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi ENDOSERVICE OPTICAL INSTRUMENTS GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78532 |
| Product Code | FBP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-14 |
| Decision Date | 2012-08-21 |
| Summary: | summary |