The following data is part of a premarket notification filed by Insight Instruments Mfg., Inc. with the FDA for Insight 4000 Endoscope.
| Device ID | K000252 |
| 510k Number | K000252 |
| Device Name: | INSIGHT 4000 ENDOSCOPE |
| Classification | Endoilluminator |
| Applicant | INSIGHT INSTRUMENTS MFG., INC. 5400 SOUTH BRYANT AVE. Sanford, FL 32773 |
| Contact | K. Peter Luloh |
| Correspondent | K. Peter Luloh INSIGHT INSTRUMENTS MFG., INC. 5400 SOUTH BRYANT AVE. Sanford, FL 32773 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-10-17 |