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K Number
K960019
Device Name
RETRACTOR ARM CLAMP
Manufacturer
BIOPSYS MEDICAL, INC.
Date Cleared
1996-02-09

(38 days)

Product Code
FWZ
Regulation Number
878.4950
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.

(a)
Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.(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 the limitations in § 878.9.