510(k) K831241

LASER LAPARAXOPE by Eder Instrument Co, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1983
Date Received
April 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type