The following data is part of a premarket notification filed by Storz with the FDA for Storz Mvs 1011a Disposable Fiberoptic Endoilluminator.
Device ID | K960007 |
510k Number | K960007 |
Device Name: | STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR |
Classification | Endoilluminator |
Applicant | STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
Contact | Audrey Swearingen |
Correspondent | Audrey Swearingen STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
Product Code | MPA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-02 |
Decision Date | 1996-03-26 |
Summary: | summary |