The following data is part of a premarket notification filed by Five Star Medical, Inc. with the FDA for Five Star Bronchoscope.
| Device ID | K960876 |
| 510k Number | K960876 |
| Device Name: | FIVE STAR BRONCHOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | FIVE STAR MEDICAL, INC. RR2 BOX 418 UNION RD. Holland, MA 01521 -9721 |
| Contact | Beverly J Stewart |
| Correspondent | Beverly J Stewart FIVE STAR MEDICAL, INC. RR2 BOX 418 UNION RD. Holland, MA 01521 -9721 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-05-08 |
| Summary: | summary |