Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K002849
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K002849
Device Name
Keratome, Ac-Powered
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
Other 510(k) Applications for this Company
Contact
VIKKI M HOFFMAN
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2000
Decision Date
10/18/2000
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact