510(k) K904248

MODEL GLASE 210 HOLMIUM LASER SYSTEM by Charles L. Rose and Co., Inc. — Product Code HGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1990
Date Received
September 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Abortion Unit, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type