Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K981109
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K981109
Device Name
Unit, Phacofragmentation
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY, UT 84119 US
Other 510(k) Applications for this Company
Contact
RICHARD DIRKSON
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/1998
Decision Date
06/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact