The following data is part of a premarket notification filed by Fiberoptic Medical Products, Inc. with the FDA for Imagica Micro-endoscope.
| Device ID | K921393 |
| 510k Number | K921393 |
| Device Name: | IMAGICA MICRO-ENDOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FIBEROPTIC MEDICAL PRODUCTS, INC. 4000 BELL ATLANTIC TOWER 1717 ARCH STREET Philadelphia, PA 19103 |
| Contact | John Reiss |
| Correspondent | John Reiss FIBEROPTIC MEDICAL PRODUCTS, INC. 4000 BELL ATLANTIC TOWER 1717 ARCH STREET Philadelphia, PA 19103 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1992-08-20 |