Needle, Biopsy, Cardiovascular, Reprocessed

NLK · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4800

Classification

FDA Product Code: NLK
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.4800
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown