The following data is part of a premarket notification filed by Kronner Prototypes, Inc. with the FDA for Kronner Laparoscopic Holder.
Device ID | K941348 |
510k Number | K941348 |
Device Name: | KRONNER LAPAROSCOPIC HOLDER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KRONNER PROTOTYPES, INC. 171 MEDICAL LOOP RD. SUITE 150 Roseburg, OR 97470 |
Contact | Richard F Kronner,m.d |
Correspondent | Richard F Kronner,m.d KRONNER PROTOTYPES, INC. 171 MEDICAL LOOP RD. SUITE 150 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 | 1994-03-21 |
Decision Date | 1994-11-14 |