The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Angiolaz Video Endoscopic System Model Camlum1 And Accessories.
| Device ID | K933868 |
| 510k Number | K933868 |
| Device Name: | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | John D Plumadore |
| Correspondent | John D Plumadore ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1993-11-10 |