The following data is part of a premarket notification filed by Quantum Loop, Inc. with the FDA for Model I 100 Rf Passive Attenuator/splitter And Model Ql 10 Loop Electrode.
| Device ID | K964779 |
| 510k Number | K964779 |
| Device Name: | MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | QUANTUM LOOP, INC. 2479 ALAMEDA DE LAS PULGAS Redwood City, CA 94061 |
| Contact | Thomas C Wehman |
| Correspondent | Thomas C Wehman QUANTUM LOOP, INC. 2479 ALAMEDA DE LAS PULGAS Redwood City, CA 94061 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-08-27 |