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510(k) Data Aggregation
K Number
K030339Device Name
CAUTERY TIP CLEANER, MODEL-TC-100
Manufacturer
ASPEN SURGICAL PRODUCTS, INC.
Date Cleared
2003-03-07
(35 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ASPEN SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.
Device Description
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K Number
K020304Device Name
DISPOSABLE LIGHT HANDLE AND ADAPTOR
Manufacturer
ASPEN SURGICAL PRODUCTS, INC.
Date Cleared
2002-02-14
(16 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ASPEN SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Light Handle is a sterile product. It is intended to be used as an accessory to Surgical Lamps. This Disposable Handle provides a sterile interface between the operating room Surgical Lamp (non-sterile), and the Surgeon or Scrub Nurse (sterile)
Device Description
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