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 |