The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Endocam Camera Systems 5502/5507 With Cr Camera Heads And Accessories.
Device ID | K982965 |
510k Number | K982965 |
Device Name: | ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Contact | Robert L Casarsa |
Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-25 |
Decision Date | 1998-11-23 |
Summary: | summary |