The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for View Md Office System, Model 41066.5540.
Device ID | K071292 |
510k Number | K071292 |
Device Name: | VIEW MD OFFICE SYSTEM, MODEL 41066.5540 |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-08 |
Decision Date | 2007-07-19 |
Summary: | summary |