510(k) K820535

LASER GAS MIXTURES by Union Carbide Corp. — Product Code EWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ent Microsurgical Carbon-Dioxide
Device Class
Class II
Regulation Number
874.4500
Review Panel
EN
Submission Type