The following data is part of a premarket notification filed by Seitz Technical Products, Inc. with the FDA for Surgical Video Camera, Model 9500.
Device ID | K902359 |
510k Number | K902359 |
Device Name: | SURGICAL VIDEO CAMERA, MODEL 9500 |
Classification | Camera, Television, Surgical, Without Audio |
Applicant | SEITZ TECHNICAL PRODUCTS, INC. 187 E. ASHLAND ST. Doylestown, PA 18901 |
Contact | Patrick Mcvay |
Correspondent | Patrick Mcvay SEITZ TECHNICAL PRODUCTS, INC. 187 E. ASHLAND ST. Doylestown, PA 18901 |
Product Code | FWB |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-29 |
Decision Date | 1990-07-12 |