The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Disposable Flexible Endoscope.
Device ID | K860771 |
510k Number | K860771 |
Device Name: | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE |
Classification | Endoscope, Flexible |
Applicant | VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
Contact | James F Vance |
Correspondent | James F Vance VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
Product Code | GCQ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-03 |
Decision Date | 1986-04-23 |