The following data is part of a premarket notification filed by American Medical Optics with the FDA for Barraquer-krumeich Refractive Set.
Device ID | K860001 |
510k Number | K860001 |
Device Name: | BARRAQUER-KRUMEICH REFRACTIVE SET |
Classification | Keratome, Ac-powered |
Applicant | AMERICAN MEDICAL OPTICS 9701 JERONIMO RD. P.O. BOX 25155 Irvine, CA 92718 |
Contact | Paul S Kramsky |
Correspondent | Paul S Kramsky AMERICAN MEDICAL OPTICS 9701 JERONIMO RD. P.O. BOX 25155 Irvine, CA 92718 |
Product Code | HNO |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-02 |
Decision Date | 1986-02-04 |