The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Electro-keratotome, Line-operated.
Device ID | K760726 |
510k Number | K760726 |
Device Name: | ELECTRO-KERATOTOME, LINE-OPERATED |
Classification | Keratome, Ac-powered |
Applicant | STORZ INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNO |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-27 |
Decision Date | 1976-10-05 |