510(k) K871514

SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID by Medical Energy, Inc. — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
April 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type