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 |