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 |