The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Double Sheath Grasping Forceps.
Device ID | K865087 |
510k Number | K865087 |
Device Name: | VAN-TEC DOUBLE SHEATH GRASPING FORCEPS |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
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 | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-30 |
Decision Date | 1987-03-25 |