The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Qualitative Keratometer M823 With Power Supply.
Device ID | K911062 |
510k Number | K911062 |
Device Name: | QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY |
Classification | Keratome, Ac-powered |
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 | HNO |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-11 |
Decision Date | 1991-05-22 |