The following data is part of a premarket notification filed by E. Benson Hood Laboratories, Inc. with the FDA for Czaja-mccaffrey Rigid Stent Introducer/endoscope.
| Device ID | K983878 |
| 510k Number | K983878 |
| Device Name: | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | E. BENSON HOOD LABORATORIES, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Anthony M Sacchetti |
| Correspondent | Anthony M Sacchetti E. BENSON HOOD LABORATORIES, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-01-29 |