The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Compuscan Lt Biometric Ruler And Iol Calculator.
Device ID | K910956 |
510k Number | K910956 |
Device Name: | COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Michael T Taggart |
Correspondent | Michael T Taggart STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-06 |
Decision Date | 1991-09-04 |