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510(k) Data Aggregation
K Number
K982884Device Name
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH
Manufacturer
NEW DEANTRONICS, LTD.
Date Cleared
1998-09-14
(28 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Device Description
New Deantronics, Inc. Model SB 312 Disposable Hand Switching Pencil, Rocker Switch, two piece.
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K Number
K982130Device Name
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
Manufacturer
NEW DEANTRONICS, LTD.
Date Cleared
1998-08-07
(51 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgery accessory. Patient return electrode conductor cable for use with the Valleylab E7509 and similar return electrode monitor compatible patient return electrodes that do not have integral cords.
Device Description
Return Electrode Clamp Shell Cord
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