The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz S6000 Light Source.
Device ID | K905376 |
510k Number | K905376 |
Device Name: | STORZ S6000 LIGHT SOURCE |
Classification | Light Source, Fiberoptic, Routine |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Susan Smith |
Correspondent | Susan Smith STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-30 |
Decision Date | 1991-01-23 |