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510(k) Data Aggregation
K Number
K980471Device Name
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
1998-04-09
(62 days)
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN INSTITUTE OF KORYO HAND THERAPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The subject of this 510(k) Notification - the KHT Guam Needle - is a sterile, single use only acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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K Number
K980472Device Name
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
1998-04-09
(62 days)
Product Code
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN INSTITUTE OF KORYO HAND THERAPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The subject of this 510(k) Notification - the KHT Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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K Number
K980470Device Name
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
1998-04-06
(59 days)
Product Code
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN INSTITUTE OF KORYO HAND THERAPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The subject of this 510(k) application - the KHT Soft Sooji Needle - is a sterilized, silicon coated, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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K Number
K980469Device Name
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
1998-04-03
(56 days)
Product Code
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN INSTITUTE OF KORYO HAND THERAPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The subject of this 510(k) application - the KHT Sooji Needle - is a sterilized, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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K Number
K974527Device Name
KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
1998-01-13
(42 days)
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN INSTITUTE OF KORYO HAND THERAPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The subject of this 510(k) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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