The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Bks-1000 Refractive Set Use In Keratorefractive.
Device ID | K870807 |
510k Number | K870807 |
Device Name: | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE |
Classification | Keratome, Ac-powered |
Applicant | ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
Contact | Paul S Kramsky |
Correspondent | Paul S Kramsky ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
Product Code | HNO |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-27 |
Decision Date | 1987-05-29 |