The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz S2050 Series Bipolar Forceps.
Device ID | K960009 |
510k Number | K960009 |
Device Name: | STORZ S2050 SERIES BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Audrey Swearingen |
Correspondent | Audrey Swearingen STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-02 |
Decision Date | 1996-03-06 |
Summary: | summary |