The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Model M705 And/or M706 Ceiling Mounted Micr..
Device ID | K903412 |
510k Number | K903412 |
Device Name: | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. |
Classification | Microscope, Surgical |
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 | EPT |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-30 |
Decision Date | 1990-09-20 |