The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz S2060-c & Dp9040 Bipolar Ccord Adaptors.
Device ID | K954253 |
510k Number | K954253 |
Device Name: | STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS |
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 | 1995-09-11 |
Decision Date | 1995-11-01 |