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 |