The following data is part of a premarket notification filed by Reda Instrumente Gmbh with the FDA for Reda Laparoscopic Instruments Ger-main Prime Endo Laparoscopic Instruments.
| Device ID | K944706 |
| 510k Number | K944706 |
| Device Name: | REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | REDA INSTRUMENTE GMBH RINGSTR. 23 Tuttlingen, DE 78532 |
| Contact | Karl Huber |
| Correspondent | Karl Huber REDA INSTRUMENTE GMBH RINGSTR. 23 Tuttlingen, DE 78532 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1994-10-20 |