The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Kelman Dipstick.
Device ID | K792383 |
510k Number | K792383 |
Device Name: | KELMAN DIPSTICK |
Classification | Caliper, Ophthalmic |
Applicant | V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOE |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-26 |
Decision Date | 1979-12-11 |