510(k) K931541

MODEL 26-0375, ELECTROSURGICAL GENERATOR by Cameron-Miller, Inc. — Product Code HGI

K931541 is an FDA 510(k) premarket notification submitted by Cameron-Miller, Inc. for the device "MODEL 26-0375, ELECTROSURGICAL GENERATOR". The FDA issued a decision of Substantially Equivalent on June 1, 1994. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Cameron-Miller, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1994
Date Received
March 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type