Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K982280
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K982280
Device Name
Unit, Cryosurgical, Accessories
Applicant
CORTEX TECHNOLOGY APS
1050 CONNECTICUT AVENUE NW
WASHINGTON, DC 20036-5339 US
Other 510(k) Applications for this Company
Contact
MARSHA WERTZBERGER
Other 510(k) Applications for this Contact
Regulation Number
878.4350
More FDA Info for this Regulation Number
Classification Product Code
GEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/1998
Decision Date
11/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact