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510(k) Data Aggregation
K Number
K961097Device Name
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
Manufacturer
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
Date Cleared
1996-06-03
(76 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
Device Description
The DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it sed to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery ... achine being used.
Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.
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K Number
K961085Device Name
DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
Manufacturer
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
Date Cleared
1996-05-21
(63 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.
Device Description
The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be the form the basis for the decise in that the Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same Multidex Plus Powder. The concept of use is that it can be easi
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K Number
K961087Device Name
DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
Manufacturer
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
Date Cleared
1996-05-16
(58 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
Device Description
The DeRoyal Surgical Electrosurgical Cautery Pencil Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical Cautery Pencil to a particular type of jack on the electrosurgical cautery machine being used.
Device Design/Materials Used/Physical Properties: The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.
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K Number
K954716Device Name
DEROYAL INDUSTRIES INFANT HEEL WARMER
Manufacturer
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
Date Cleared
1996-01-11
(90 days)
Product Code
MPO
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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