The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Pyramid Trocar, 10mm W/spring Ret. Protective Sleeve Or Trocar W/spring Loaded Protection Sleeve.
Device ID | K960299 |
510k Number | K960299 |
Device Name: | PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Contact | Robert Casarsa |
Correspondent | Robert Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-22 |
Decision Date | 1996-10-28 |
Summary: | summary |