The following data is part of a premarket notification filed by Emory University School Of Medicine with the FDA for H200 Hanna Suction Trephine System For Corneal Sur.
Device ID | K896473 |
510k Number | K896473 |
Device Name: | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR |
Classification | Magnet, Permanent |
Applicant | EMORY UNIVERSITY SCHOOL OF MEDICINE 1327 CLIFTON RD., N.E. Atlanta, GA 30322 |
Contact | Hanna, Md |
Correspondent | Hanna, Md EMORY UNIVERSITY SCHOOL OF MEDICINE 1327 CLIFTON RD., N.E. Atlanta, GA 30322 |
Product Code | HPN |
CFR Regulation Number | 886.4445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-13 |
Decision Date | 1990-02-09 |