Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K003036
Device Classification Name
Device, Irrigation, Ocular Surgery
More FDA Info for this Device
510(K) Number
K003036
Device Name
Device, Irrigation, Ocular Surgery
Applicant
RETINALABS.COM
1776 PEACHTREE ST.
200 NORTH
ATLANTA, GA 30309 US
Other 510(k) Applications for this Company
Contact
FRANK TIGHE
Other 510(k) Applications for this Contact
Regulation Number
886.4360
More FDA Info for this Regulation Number
Classification Product Code
KYG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2000
Decision Date
12/22/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact