The following data is part of a premarket notification filed by Kronner Prototypes, Inc. with the FDA for Kronner Low Profile Scope Holder.
| Device ID | K973543 |
| 510k Number | K973543 |
| Device Name: | KRONNER LOW PROFILE SCOPE HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
| Contact | Crystal Kronner |
| Correspondent | Crystal Kronner KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1998-01-12 |
| Summary: | summary |