The following data is part of a premarket notification filed by Five Star Medical, Inc. with the FDA for 5 Star Medical Endoscope.
| Device ID | K963354 |
| 510k Number | K963354 |
| Device Name: | 5 STAR MEDICAL ENDOSCOPE |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | FIVE STAR MEDICAL, INC. 4767 WREN COURT Charlottesville, VA 22911 |
| Contact | Beverly J Stewart |
| Correspondent | Beverly J Stewart FIVE STAR MEDICAL, INC. 4767 WREN COURT Charlottesville, VA 22911 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1997-09-08 |
| Summary: | summary |