The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Dps 100 Multiport Illumination System (mis).
Device ID | K933445 |
510k Number | K933445 |
Device Name: | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) |
Classification | Transilluminator, Ac-powered |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Michael H Southworth |
Correspondent | Michael H Southworth STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | HJM |
CFR Regulation Number | 886.1945 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-13 |
Decision Date | 1994-09-23 |