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K Number
K963234
Device Name
STAPLE REMOVAL KIT
Manufacturer
CONTINENTAL MEDICAL LABORATORIES, INC.
Date Cleared
1996-10-21

(63 days)

Product Code
GDT
Regulation Number
878.4760
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 878.4760 Removable skin staple.

(a)
Identification. A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.