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882.4650—Neurosurgical suture needle.
(a) Identification.
A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
(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 § 882.9.
Code of Federal Regulations
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