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510(k) Data Aggregation
K Number
K970254Device Name
SEIRIN PYONEX ACUPUNCTURE NEEDLES
Manufacturer
SEIRIN-AMERICA, INC.
Date Cleared
1997-02-10
(19 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEIRIN-AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pyonex acupuncture needles are (defined as) devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Device Description
The Seirin PYONEX Acupuncture Needle is a sterile, single use only acupuncture needle. The Seirin PYONEX Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
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K Number
K970260Device Name
SEIRIN JR ACUPUNCTURE NEEDLES
Manufacturer
SEIRIN-AMERICA, INC.
Date Cleared
1997-02-10
(18 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEIRIN-AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seirin JR acupuncture needles are (defined as) devices intended 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 Seirin JR Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin JR Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
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K Number
K963769Device Name
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
Manufacturer
SEIRIN-AMERICA, INC.
Date Cleared
1996-10-16
(27 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEIRIN-AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acupuncture needles are defined as devices intended 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 Seirin Spinex acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin Spinex acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
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K Number
K962809Device Name
SEIRIN ACUPUNCTURE NEEDLES
Manufacturer
SEIRIN-AMERICA, INC.
Date Cleared
1996-08-16
(29 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEIRIN-AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acupuncture needles are defined as devices intended 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 Seirin acupuncture needle - is a sterile, single use only acupuncture needle. The Seirin acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
Ask a Question
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