510(k) K823293

MEDIGROUP LG-102 LIGHT GUIDE by Medigroup — Product Code HET

K823293 is an FDA 510(k) premarket notification submitted by Medigroup for the device "MEDIGROUP LG-102 LIGHT GUIDE". The FDA issued a decision of Substantially Equivalent on May 5, 1983. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Medigroup has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
November 5, 1982
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