The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Laparoscope.
| Device ID | K143221 |
| 510k Number | K143221 |
| Device Name: | Schoelly Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Schoelly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen, DE 79211 |
| Contact | Sandra Baumann |
| Correspondent | Pamela Papineau, Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2014-12-05 |
| Summary: | summary |